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Dissolution Methods

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (mL) Recommended Sampling Times (minutes) Date Updated
Abacavir Sulfate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Abacavir Sulfate/Dolutegravir Sodium/Lamivudine Tablet (For Suspension) II (Paddle) 50 0.01 M Phosphate Buffer with 0.5 mM EDTA, pH 6.8 500 5, 10, 15, 30, 45 and 60 10/06/2023
Abacavir Sulfate/Dolutegravir Sodium/Lamivudine Tablet II (Paddle) 85 0.01 M Phosphate Buffer with 0.5% sodium dodecyl sulfate (SDS), pH 6.8 900 Abacavir and lamivudine: 10, 15, 20, 30 and 45; Dolutegravir: 5,15, 25, 35 and 45. 05/28/2015
Abacavir Sulfate/Lamivudine Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, and 45  01/03/2007
Abacavir Sulfate/Lamivudine/Zidovudine Tablet II (Paddle) 75 0.1 N HCl Acid Stage: 900 mL; Buffer Stage: 1000 mL 5, 10, 15, 30 and 45 01/03/2007
Abemaciclib Tablet II (Paddle) 75 0.01 N HCl 900 5, 10, 15, 20 and 30 11/16/2017
Abiraterone Acetate Tablet II (Paddle) 50 0.25% SLS in 56.5 mM phosphate buffer, pH 4.5 900 10, 20, 30, 45 and 60  02/28/2013
Abrocitinib Tablet II (Paddle) with peak vessels 55 Citrate-phosphate buffer, pH 3.5 900 10, 20, 30 and 45 05/18/2023
Acalabrutinib Capsule II (Paddle) 50 0.1 N HCl 900 10, 15, 20 and 30 08/17/2023
Acamprosate Calcium Tablet (Delayed Release) I (Basket) 180 Acid Stage: 0.1 N HCl Buffer Stage: "Citrate-sodium hydroxide" buffer pH 6.8 (150 ml of 2N NaOH, 21.014 gm of citric acid and ultra-pure water to 1000 ml) (Method B) Media 1: 750 mL pH 1.1±0.1; Media 2: 950 mL pH 6.0±0.1; Media 3: 1000 mL pH 7.5±0.1 120 (Acid) 30, 60, 90, 120, and 180 (buffer) 12/20/2005
Acarbose Tablet Develop a dissolution method 09/15/2023
Acarbose Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Acetaminophen Suppository II (Paddle) 50 Phosphate buffer, pH 5 900 15, 30, 45, 60 and 90 08/17/2006
Acetaminophen Tablet (Extended Release)  Refer to USP 03/03/2011
Acetaminophen/Aspirin/Caffeine Tablet Develop a dissolution method 01/03/2024
Acetaminophen/Butalbital Tablet Develop a dissolution method 09/15/2023
Acetaminophen/Butalbital/Caffeine Tablet Develop a dissolution method 01/03/2024
Acetaminophen/Butalbital/Caffeine/Codeine Phosphate Capsule    Develop a dissolution method 09/15/2023
Acetaminophen/Caffeine/Dihydrocodeine Bitartrate Capsule Develop a dissolution method 09/15/2023
Acetaminophen/Caffeine/Dihydrocodeine Bitartrate Tablet Develop a dissolution method 09/15/2023
Acetaminophen/Hydrocodone Bitartrate Tablet Refer to USP (provide individual unit data). 08/15/2013
Acetaminophen/Ibuprofen Tablet II (Paddle) 50 50 mM Phosphate Buffer, pH 7.2 900 5, 10, 15, 20, and 30 02/09/2023
Acetaminophen/Oxycodone Tablet Refer to USP 01/14/2008
Acetaminophen/Oxycodone HCl Tablet (Extended Release) II (Paddle) with sinker 100 0.1 N HCl 900 0.25, 0.5, 1, 2, 4, 6 and 8 hours 11/19/2015
Acetaminophen/Pentazocine HCl Tablet Develop a dissolution method 09/15/2023
Acetaminophen/Tramadol HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 03/04/2006
Acetaminophen; Butalbital Capsule Develop a dissolution method 02/05/2024
Acetazolamide Capsule (Extended Release) II (Paddle) 75 Acetate Buffer, pH 4.5 with 2.2% Tween 20 900 1, 2, 5, 7, 9, 12 and 14 hours 01/15/2010
Acetazolomide Tablet Develop a dissolution method 01/03/2024
Acetylcysteine Tablet (Effervescent) Develop a dissolution method 07/28/2016
Acitretin Capsule Refer to USP  09/22/2011
Acrivastine/Pseudoephedrine HCl Capsule II (Paddle) 50 0.01 N HCl 900 5, 10, 15 and 30 01/12/2004
Acyclovir Suspension II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 02/20/2004
Acyclovir Capsule Refer to USP  01/05/2012
Acyclovir Tablet (Buccal) I (Basket) 60 Phosphate Buffer, pH 6.0 1000 1, 2, 3, 5, 7, 9 and 12 hours 08/27/2015
Acyclovir Tablet Refer to USP 06/18/2007
Adagrasib Tablet II (Paddle) 75 pH 6.8 phosphate buffer with 0.3% SLS 900 10, 15, 30, 45 and 60 02/05/2024
Adefovir Dipivoxil Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Afamelanotide Implant Develop a method to characterize in vitro release 05/18/2023
Afatinib Dimaleate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Albendazole Tablet (Chewable) II (Paddle)  50 0.1 N HCl 900 10, 15, 20, 30 and 45 03/17/2016
Albendazole Tablet  Refer to USP  08/15/2013
Albuterol Sulfate Tablet (Extended Release) II (Paddle) 50 0.1 N HCl 900 1, 2, 4, 6, 9 and 12 hours 04/09/2007
Albuterol Sulfate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Alectinib HCl Capsule  II (Paddle) with sinker  100 pH 1.2, Simulated Gastric Fluid without pepsin, containing 4 % Triton X-100 [polyoxyethylene[10]octylphenyl ether] 900 10, 20, 30, 45, 60, 75 and 90 03/17/2016
Alendronate Sodium Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Alendronate Sodium/Cholecalciferol Tablet Develop a dissolution method 09/15/2023
Alfuzosin HCl Tablet (Extended Release) II (Paddle) 100 0.01 N HCl 900 1, 2, 12, 20 hours 06/18/2007
Aliskiren Hemifumarate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Aliskiren Hemifumarate Capsule (pellet) I (Basket) 100 0.01 M HCl (degas) 500 5, 10, 15, 20, 30 and 45 02/08/2018
Aliskiren Hemifumarate/Amlodipine Besylate Tablet I (Basket)  100 0.01 N HCl, pH 2.0 500 10, 15, 20, 30 and 45  06/07/2012
Aliskiren Hemifumarate/Amlodipine Besylate/Hydrochlorothiazide Tablet I (Basket)  100 0.01 N HCl 900 10, 15, 20, 30 and 45  06/07/2012
Aliskiren Hemifumarate/Hydrochlorothiazide Tablet I (Basket) 100 0.1 N HCl  900 10, 15, 20, 30 and 45 10/08/2009
Aliskiren Hemifumarate/Valsartan Tablet  I (Basket) 100 Phosphate Buffer, pH 6.8 1000 5, 10, 15, 20, 30 and 45  12/23/2010
Allopurinol Tablet Refer to USP 07/25/2007
Almotriptan Malate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Alogliptin Benzoate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Alogliptin Benzoate/ Metformin HCl Tablet II (Paddle) 50 0.01 N HCl 900 5, 10, 15, 20 and 30 11/19/2015
Alosetron HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Alprazolam Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Alprazolam Tablet (Extended Release) I (Basket) 100 1% Phosphate Buffer, pH 6.0 500 1, 4, 8, 12 and 16 hours 02/08/2007
Alprazolam Tablet (Orally Disintegrating) II (Paddle) 50 70 mM Potassium Phosphate Buffer, pH 6.0 500 2, 5, 10, 15 and 20 10/06/2008
Altretamine Capsule Refer to USP  01/29/2010
Aluminum Hydroxide/Magnesium Trisilicate Tablet (Chewable) Develop a dissolution method 05/12/2022
Alvimopan Capsule II (Paddle 50 0.1 N HCl 900 5, 10, 15, 20, 30 and 45  10/21/2010
Amantadine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Amantadine HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Ambrisentan Tablet II (Paddle) 75 0.05 M Acetate Buffer, pH 5.0 900 5, 10, 15, 30, and 45 05/20/2009
Amifampridine Tablet Refer to FDA's Dissolution Guidance, 2018 08/19/2021
Amifampridine Phosphate Tablet Refer to FDA's Dissolution Guidance, 2018 08/19/2021
Amiloride HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Amiloride HCl/Hydrochlorothiazide Tablet Refer to USP 06/07/2012
Aminocaproic Acid Tablet Refer to FDA's Dissolution Guidance, 2018 01/03/2024
Aminosalicylic Granule (Delayed Release) II (Paddle) 100 Acid Stage: 0.1 N HCl; Buffer Stage 2: pH 7.5 Phosphate Buffer 1000 Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours 07/14/2008
Amiodarone HCl (Test 1) Tablet Develop a dissolution method 09/15/2023
Amiodarone HCl (Test 2) Tablet I (Basket) 50 Acetate Buffer, pH 4.0, with 1% Tween 80 900 10, 20, 30, 45, 60 and 90 01/12/2004
Amitriptyline HCl Tablet Refer to USP 01/14/2008
Amlodipine Besylate Tablet (Orally Disintegrating) II (Paddle) 50 0.01 N HCl 500 5, 10, 15 and 20 10/06/2008
Amlodipine Besylate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Amlodipine Besylate/Atorvastatin Calcium Tablet II (Paddle) 75 Phosphate Buffer, pH 6.8 900 5, 10, 15 and 30 04/02/2009
Amlodipine Besylate/Benazepril HCl Capsule I (Basket) 100 0.01 N HCl 500 10, 20 , 30, 45, and 60 06/20/2007
Amlodipine Besylate/Hydrochlorothiazide/Olmesartan Medoxomil Tablet  II (Paddle)  50 Phosphate Buffer, pH 6.8 900 5, 10, 15, 20, 30 and 45 07/21/2011
Amlodipine Besylate/Hydrochlorothiazide/Valsartan Tablet  Refer to USP  07/28/2016
Amlodipine Besylate/Olmesartan Medoxomil Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 900 10, 20, 30 and 45 08/11/2008
Amlodipine besylate/Perindopril Arginine Tablet  II (Teflon coated paddle) 75 0.01 N HCL 1000 5, 10, 15, 20 and 30 03/17/2016
Amlodipine Besylate/Telmisartan Tablet II (Paddle) 75 Telmisartan: Phosphate Buffer, pH 7.5; Amlodipine: 0.01N HCl, pH 2 Telmisartan: 900; Amlodipine: 500 Telmisartan: 10, 15, 20, 30 and 45; Amlodipine: 10, 15, 20, 30 and 45 08/05/2010
Amlodipine Besylate/Valsartan Tablet  Refer to USP  07/28/2016
Amoxicillin Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Amoxicillin Tablet (Extended Release)  II (Paddle) 100 3 Stage dissolution: 50 mM potassium phosphate monobasic buffer at pH 4.0 (0-2 hours), 6.0 (2-4 hours) and 6.8 ( 4 hours and beyond) 900 0.25, 0.5, 1, 2, 2.25, 2.5, 3, 4, 4.25, 4.5, 5 and 6 hours 10/21/2010
Amoxicillin Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Amoxicillin For Oral Suspension  Develop a dissolution method 09/15/2023
Amoxicillin/Clarithromycin/Lansoprazole Capsule/Tablet/Capsule (Copackage) Develop a dissolution method for Amoxicillin Capsules, Refer to USP for monographs of Clarithromycin Tablets and Lansoprazole Delayed-Release Capsules 01/03/2024
Amoxicillin/Clarithromycin/Omeprazole Capsule/Tablet/Capsule (Copackage) Develop a dissolution method for Amoxicillin Capsules, Refer to USP for monographs of Clarithromycin Tablets and Omeprazole Delayed-Release Capsules 01/03/2024
Amoxicillin/Clavulanate Potassium Tablet  Develop a dissolution method 01/03/2024
Amoxicillin/Clavulanate Potassium Suspension Develop a dissolution method 09/15/2023
Amoxicillin/Clavulanate Potassium Tablet (Chewable) Develop a dissolution method 09/15/2023
Amoxicillin/Omeprazole Mg./Rifabutin Capsule (Delayed Release) I (Basket 100 Amoxicillin/Rifabutin: 0.01 N HCl; Omeprazole: 0.1N HCl; Buffer Stage: 0.05M Phosphate buffer, pH 6.8 Amoxicillin/Rifabutin:900; Omeprazole: Acid Stage: 900; Buffer Stage:900; Amoxicillin/Rifabutin: 5, 10, 15, 20 and 30; Omeprazole: Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30; 08/27/2020
Amoxicillin; Clarithromycin; Vonoprazan Fumarate Capsule, Tablet, Tablet Clarithromycin and Vonoprazan: II (Paddle) Clarithromycin and Vonoprazan: 50 Amoxicillin: Develop a dissolution method; Clarithromycin: 0.1M Sodium Acetate Buffer (pH 5.0); Vonoprazan: 0.05M Acetate Buffer (pH 4.5) 900 10, 15, 30, 45, 60 and 90 02/05/2024
Amoxicillin; Vonoprazan Fumarate Capsule, Tablet Vonoprazan: II (Paddle) Vonoprazan: 50 Amoxicillin: Develop a dissolution method; Vonoprazan: 0.05M Acetate Buffer (pH 4.5) 900 10, 15, 30, 45, 60 and 90 02/05/2024
Amphetamine Tablet (Extended Release, Orally Disintegrating) II (Paddle  75 Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 Acid Stage: 900 mL; Buffer Stage: 1000 mL Acid Stage: 10, 15, 30, 45, 60, 90, 120; Buffer Stage: 5, 10, 15, 30 and 45 07/28/2016
Amphetamine Suspension (Extended Release)   Develop a dissolution method 12/22/2016
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate Capsule (Extended Release) II (Paddle) 50 Dilute HCl, pH 1.1 for first 2 hrs, then add 200 mL of 200 mM Phosphate Buffer and adjust to pH 6.0 for the remainder 0-2 hrs: 750 mL. After 2 hrs: 950 mL 0.5, 1, 2, 3, and 4 hours 07/25/2007
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate Tablet Develop a dissolution method 09/15/2023
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate [12.5, 25, 37.5, 50 mg] Capsule (Extended Release) II (Paddle) 50 Media 1: pH 1.1±0.1, Dilute HCl 2 hours; Media 2: pH 6.0±0.1, Phosphate Buffer 3rd hour, Media 3: pH 7.5±0.1, Phosphate Buffer for the remainder Media 1: 750 mL; Media 2: 950 mL; Media 3: 1000 mL 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours 11/16/2017
Amphetamine ER Capsule II (Paddle) 50 750 ml of dilute HCl, pH 1.1 for the first 2 hours, then add 200 ml of 200 mM phosphate buffer, and adjust to pH 6 (w/ HCl or NaOH) for the remainder 750 ml of dilute HCl, 200 ml of phosphate buffer 1, 2, 3, 4, and 6 hours 08/17/2006
Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate Tablet (Extended Release) II (Paddle) 50 Stage 1: 500 mL of water for 1 hour; Stage 2: 700 mL of 0.001N HCl for next 2 hours (add 200 mL of HCl to Stage 1); Stage 3: 900 mL of Phosphate Buffer, pH 6.8 (add 200 mL of Potassium Phosphate Buffer to Stage 2) Stage 1: 500; Stage 2: 700; Stage 3: 900 1, 3, 3.17, 3.25, 3.5, 3.75, 4, 6, 8 and 12 hours 05/12/2022
Amphotericin B Injectable (Liposomal)   Develop a method to characterize in vitro release 07/28/2016
Ampicillin/Ampicillin Trihydrate Capsule Develop a dissolution method 09/15/2023
Ampicillin/Ampicillin Trihydrate for Oral Suspension Develop a dissolution method 09/15/2023
Amprenavir Capsule II (Paddle) 50 0.1 N HCl 900 10, 15, 30, and 45 02/19/2008
Anagrelide HCl Capsule I (Basket) 100 0.1 N HCl 900 5, 10, 15, 30 and 45 01/14/2004
Anastrozole Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Apalutamide Tablet II (Paddle) 75 0.25% sodium lauryl sulfate (SLS) in 0.05 M Sodium Phosphate Buffer, pH 4.5 (60 mg strength); 0.5% sodium lauryl sulfate (SLS) in 0.05 M Sodium Phosphate Buffer, pH 4.5 (240 mg strength) 900 5, 10, 15, 20, 30, and 45 02/16/2024
Apixaban Tablet II (Paddle)  75 0.05 M Sodium Phosphate Buffer with 0.05% SLS, pH 6.8 900 5, 10, 20, 30 and 45 05/09/2013
Apomorphine HCl Film (Sublingual)  V (paddle over disk) 75 20mM BIS-TRIS HCl Buffer, pH 6.4 500 2.5, 5, 7.5, 10, 12.5, 15 and 20 08/19/2021
Apremilast Tablet II (Paddle) 60 0.15% SLS in 25 mM Sodium Phosphate Buffer, pH 6.8 900 10, 15, 20, 30, and 45  05/18/2017
Aprepitant For Oral Suspension   Develop a dissolution method 09/15/2023
Aprepitant Capsule Develop a dissolution method 09/15/2023
Aprepitant Emulsion Develop a method to characterize in vitro release 02/05/2024
Aripiprazole For Intramuscular Suspension (Extended Release) II (Paddle) 50 0.25% Sodium Dodecyl Sulfate (SDS) Solution 900 10, 15, 30, 60, 120, 180, 240, 300, 360, 420 and 480 06/25/2015
Aripiprazole Tablet  Refer to USP  06/30/2016
Aripiprazole Tablet (Orally Disintegrating) II (Paddle) 75 Acetate Buffer, pH 4.0 1000 10, 20, 30 and 45 08/11/2008
Armodafinil Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 01/14/2008
Asciminib HCl Tablet II (Paddle) 60 Citrate Buffer, pH 3.0 900 5, 10, 15, 20 and 45 10/06/2023
Asenapine Transdermal VI (Cylinder) 50 pH 5.1 Acetate Buffer at 32°C 900 1, 2, 3, 4, 6, 8, 10 and 12 hours 04/22/2021
Asenapine Maleate Tablet (Sublingual)  II (Paddle)  50 Acetate Buffer, pH 4.5  500 1, 2, 3, 4 and 5 05/09/2013
Aspirin Capsule (Extended Release)  II (Paddle) with sinker 100 0.05M Potassium Phosphate Buffer (pH 7.4) with trypsin (.001%w/v) and sodium azide (.025% w/v) 900 1, 2, 3, 6, 9, 12, 16, 22 and 30 hours 10/20/2016
Aspirin Capsule Refer to USP 05/28/2015
Aspirin/ Omeprazole Tablet (Delayed Release)  I (Basket) 100 Acid Stage: 0.1 N HCl (degassed); Buffer Stage: Phosphate Buffer, pH 6.8 (degassed) Acid Stage: 900; Buffer Stage: 900 Acid Stage:120; Buffer Stage:10, 20, 30, 45, 60 and 75 12/22/2016
Aspirin/Butalbital/Caffeine Capsule Develop a dissolution method 01/03/2024
Aspirin/Butalbital/Caffeine Tablet Develop a dissolution method 01/03/2024
Aspirin/Butalbital/Caffeine/Codeine Phosphate Capsule Develop a dissolution method 01/03/2024
Aspirin/Caffeine/Orphenadrine Citrate Tablet Develop a dissolution method 09/15/2023
Aspirin/Dipyridamole Capsule I (Basket) 100 0.01 N HCl for first hour, 0.1 M Phosphate Buffer, pH 5.5, thereafter 0-1 hrs: 900 mL. 900 mL thereafter Acid: 10, 20, 30, 45 and 60 min; Buffer:1, 2, 5, and 7 hours 10/09/2007
Aspirin/Hydrocodone Bitartrate Tablet II (Paddle) 75 Acetate Buffer, pH 4.5 900 10, 20, 30, 45, 60 and 90 01/15/2004
Aspirin/Meprobamate Tablet Develop a dissolution method 09/15/2023
Aspirin/Methocarbamol Tablet Develop a dissolution method 09/15/2023
Aspirin/Oxycodone HCl Tablet Refer to USP  01/15/2010
Atazanavir Sulfate Capsule II (Paddle) 50 0.025 N HCl 1000 10, 20, 30 and 45 01/20/2006
Atazanavir Sulfate/ Cobicistat Tablet II (Paddle) 75 0.05 M Citrate Buffer (pH 2.8) 1000 Atazanavir: 10, 15, 20, 30 and 45; Cobicistat: 5, 10, 15, 20 and 30 12/24/2015
Atenolol Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Atenolol/Chlorthalidone Tablet  Refer to USP  02/14/2014
Atogepant Tablet Refer to FDA's Dissolution Guidance, 2018 05/18/2023
Atomoxetine HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Atorvastatin Calcium Tablet II (Paddle) 75 0.05 M Phosphate buffer, pH 6.8 900 5, 10, 15 and 30 01/15/2004
Atorvastatin Calcium/Ezetimibe Tablet II (Paddle), with option to use a sinker for 20/10 mg strength 75 Phosphate buffer, pH 6.8 with 0.2% w/v Tween 80 900 5, 10, 15, 20, 30 and 45 05/15/2014
Atovaquone Oral Suspension Develop a dissolution method   07/21/2009
Atovaquone Tablet II (Paddle) 50 40% isopropanol buffered to pH 8.0 with potassium dihydrogen phosphate 900 10, 20, 30, 45, 60 and 90 06/18/2007
Atovaquone/Proguanil HCl Tablet II (Paddle) with PEAK vessels 50 40% isopropranol buffered to pH 8.0 with potassium dihydrogen phosphate 900 15, 30, 45 and 60 08/17/2006
Atropine Sulfate/ Diphenoxylate HCl Tablet  Develop dissolution method(s) to characterize the dissolution of both components 12/22/2016
Auranofin Capsule Develop a dissolution method 09/15/2023
Avacopan Capsule II (Paddle) with sinker 50 0.1N HCl 900 10, 20, 30, 45 and 60 10/06/2023
Avanafil Tablet  II (Paddle) 50 Simulated gastric fluid without pepsin. 900 5, 10, 15, 20 and 30 04/02/2015
Avapritinib Tablet II (Paddle) 75 0.05 M Sodium Acetate Buffer, pH 5.0 containing 0.5% w/v cetyl trimethylammonium bromide (CTAB) 900 5, 10, 15, 20, 30, 45, 60, 90 and 120 05/12/2022
Axitinib Tablet  II (Paddle) 75 0.01 N HCl 900 5, 15, 30, 45 and 60 08/14/2014
Azacitidine Tablet II (Paddle) 75 50 mM phosphate buffer, pH 6.8 500 5, 10, 15, 20, 30 and 45 11/30/2023
Azacitidine Injectable Suspension Develop a dissolution method 09/03/2008
Azathioprine Tablet Develop a dissolution method 01/03/2024
Azilsartan Kamedoxomil Tablet II (Paddle)  50 Phosphate Buffer, pH 7.8 (deaerated) 900 5, 10, 15, 20, 30 and 45 05/09/2013
Azilsartan Kamedoxomil/Chlorthalidone Tablet II (Paddle)  50 Phosphate Buffer, pH 6.8 containing 1.0% Tween 80, 900 5, 10, 15, 20, 30 and 45 05/09/2013
Azithromycin Oral Suspension II (Paddle) 50 Phosphate buffer, pH 6.0 900 10, 20, 30, and 45 08/17/2006
Azithromycin Tablet  Refer to USP  12/22/2016
Azithromycin Capsule Refer to USP  12/22/2016
Azithromycin Suspension (Extended Release) II (Paddle) 50 Phosphate Buffer, pH 6.0 900 15, 30, 45, 60, 120 and 180 04/15/2008
Baclofen Tablet (Orally Disintegrating) II (Paddle) 25 50 mM Acetate Buffer, pH 4.5 500 mL (10 mg) or 1000 mL (20mg) 5, 10, 15 and 30 07/14/2008
Baclofen Granules II (Paddle) 50 0.01 N HCl 500 5, 10, 15 and 30 02/05/2024
Baclofen Tablet Refer to USP 12/15/2009
Baloxavir Marboxil Tablet II (paddle) 50 20 mg: Phosphate Buffer, pH 6.8 with 0.07% w/v (CTAB); 40 mg: Phosphate Buffer, pH 6.8 with 0.16% w/v CTAB; 80 mg: Phosphate Buffer, pH 6.8 with 0.40 w/v cetyltrimethylammonium bromide (CTAB) 900 5, 10, 15, 20, 30 and 45 07/07/2023
Baloxavir Marboxil For Suspension II (Paddle) 25 Phosphate Buffer, pH 6.8 containing 0.16% w/v cetyl trimethylammonium bromide (CTAB) 900 5, 10, 15, 20 and 30 02/09/2023
Balsalazide Disodium Capsule II (Paddle) with sinker 50 pH 6.8 buffer 900 10, 20, 30, and 45 01/26/2006
Balsalazide Disodium Tablet Develop a dissolution method 09/15/2023
Baricitinib Tablet II (Paddle) 75 Acetate buffer pH 4.5 900 5, 15, 30, 45 03/30/2023
Bedaquiline Fumarate Tablet  I (Basket) 150 0.01 N HCl 900 10, 15, 20, 30 and 45 06/06/2013
Belzutifan Tablet II (Paddle) 50 50 mM potassium phosphate buffer at pH 6.5 with 68 mM potassium chloride (@37°C) 900 10, 15, 20, 30, 45 and 60 07/07/2023
Bempedoic Acid Tablet II (Paddle)  50 0.05 M Phosphate buffer, pH 6.6 900 5, 10, 15, 20 and 30 08/19/2021
Bempedoic Acid/Ezetimibe Tablet II (Paddle)  50 Bempedoic Acid: 0.05 M Phosphate buffer, pH 6.6; Ezetimibe: 0.05M Sodium Acetate Buffer pH 4.5 with 0.45% SLS 900 5, 10, 15, 20, 30, and 45 08/19/2021
Benazepril HCl Tablet Develop a dissolution method 09/15/2023
Benazepril HCl/Hydrochlorothiazide Tablet I (Basket) 100 0.1 N HCl 500 10, 20, 30 and 45 01/16/2004
Bendroflumethiazide/Nadolol Tablet Refer to USP 07/25/2007
Benzonatate Capsule Develop a dissolution method 01/03/2024
Benzoyl Peroxide; Clindamycin Phosphate Gel Develop a method to characterize in vitro release 05/18/2023
Benzphetamine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Bepridil HCl Tablet I (Basket) 100 0.1 N HCl 900 10, 20, 30, 45 and 60 01/16/2004
Berotralstat HCl Capsule Refer to FDA's Dissolution Guidance, 2018 02/09/2023
Betamethasone Acetate/Betamethasone Sodium Phosphate Injectable Suspension IV (Flow through cell) Flow @ 8 mL/min 0.05% SLS, pH 3.0 or Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, and 360 04/08/2010
Bethanechol Chloride Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Bethanechol Chloride Tablet Refer to USP 10/06/2008
Betrixaban Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Bexarotene Capsule II (Paddle) 50 Tier 1 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 Tier 2 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 with 0.05 g/L pancreatin enzyme 900 15, 30, 45 and 60 08/17/2006
Bicalutamide Tablet Develop a dissolution method 09/15/2023
Bimatoprost Implant Develop a method to characterize in vitro release 07/07/2023
Bisacodyl/Polyethylene glycol 3350/ Potassium Chloride/Sodium Bicarbonate/ Sodium Chloride Tablet (Delayed Release), For Solution, II (Paddle) 100 Acid stage: 0.1 N HCl: Buffer stage: 0.05 M Phosphate buffer, pH 6.8, with 0.15% sodium lauryl sulfate (SLS) [only for Bisacodyl Tablets] Acid stage: 900 mL; Buffer stage: 900 mL Acid stage: 60; Buffer stage: 10, 20, 30, 45 and 60 03/02/2017
Bismuth Subcitrate Potassium/Metronidazole/Tetracycline HCl Capsule Develop a dissolution method 09/15/2023
Bismuth Subsalicylate (BiSub)/Metronidazole (Met)/Tetracycline HCl (Tet) BiSub: Tablet (Chewable) /Met:Tablet /Tet: Capsule II (Paddle) 50 BiSub: 0.1 N HCl /Met: Refer to USP /Tet: Refer to FDA's Dissolution Guidance, 2018 900 5, 10, 15, 20 and 30  07/07/2022
Bisoprolol Fumarate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Bisoprolol Fumarate/Hydrochlorothiazide Tablet II (Paddle) 75 0.1 N HCl 900 5, 10, 20, 30 and 45 01/20/2004
Boceprevir Capsule II (Paddle) with sinker 50 50 mM phosphate buffer, pH 6.8 with 0.1% sodium dodecyl sulfate  900 10, 20, 30, 45, 60 and 75  01/31/2013
Bosentan Tablet Develop a dissolution method 09/15/2023
Bosentan Tablet (For Suspension) II (Paddle) 75 0.1 N HCl with 0.5% sodium dodecyl sulfate (SDS), pH 1.1 900 5, 10, 15, 20 and 30 11/16/2017
Bosutinib Monohydrate Tablet  II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 45 06/25/2015
Brexpiprazole Tablet II (Paddle) 50 0.05 M Acetate buffer, pH 4.3 900 10, 15, 20, 30 and 45 10/20/2016
Brigatinib Tablet II (Paddle) 70 50 mM Potassium Phosphate Buffer, pH 7.2 900 5, 10, 15, 20, 30 and 45 11/02/2017
Brimonidine Tartrate/Brinzolamide Ophthalmic Suspension Develop a method to characterize in vitro release 01/15/2015
Brincidofovir Tablet I (Basket) 50 50 mM sodium phosphate buffer, pH 6.4 + 0.3% SDS 900 5, 10, 15, 20, 30, 45, 60, 75 and 90 07/07/2023
Brincidofovir Suspension II (Paddle) 50 0.05 M Sodium Phosphate Monobasic, Monohydrate Buffer, pH 6.4 + 0.05% Tween 80 900 5, 10, 15, 20, 30, 45, 60, 75 and 90 07/07/2023
Brinzolamide Ophthalmic Suspension  Develop a method to characterize in vitro release  09/01/2011
Brivaracetam Tablet  II (Paddle  50 Phosphate Buffer, pH 6.4 2.5 and 5 mg tablets: 500 mL; 10, 25, 50, 75 and 100 mg tablets: 900 mL 5, 10, 15, 20 and 30 07/28/2016
Bromocriptine Mesylate Tablet Refer to USP 07/25/2007
Budesonide Tablet (Extended Release) II (Paddle) 100 Acid Stage: 0.1 M HCl containing 0.5% Macrogol Cetostearyl Ether; Buffer Stage: pH 7.2 phosphate buffer containing 0.5% Macrogol Cetostearyl Ether. Acid Stage: 500 mL ; Buffer Stage: 1000 mL Acid Stage: 2 hours; Buffer Stage: 1, 2, 4, 6, 8 and 10 hours 04/02/2015
Budesonide Capsule II (Paddle) with sinker 75 Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 7.5  Acid stage: 1000; Buffer stage: 1000 Acid stage: 2 hours; Buffer stage: 0.25, 0.5, 1, 2, 4, 6 and 8 hours 02/25/2015
Bumetanide Tablet Develop a dissolution method 01/03/2024
Bupivacaine Solution (Extended Release), Infiltration II (Paddle) 50 0.025 M Sodium Phosphate Buffer with 0.03% Sodium Dodecyl Sulfate (SDS), pH 7.4 900 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours 07/07/2022
Buprenorphine Film, Transdermal (Extended Release)  VI (Cylinder) with adapter, if needed 50 0.9% Sodium Chloride at 32°C 600 0.5,1, 2, 4, 6, 8,12, 16 and 24 hours  05/09/2013
Buprenorphine HCl Film (Buccal) I (Basket)  100 mL round bottom vessel 100 0.05M NaH2PO4.H2O Phosphate Buffer, pH 4.5 60 10, 15, 20, 30, 45 and 60 10/20/2016
Buprenorphine HCl Implant II (Paddle)  50 Water 900 1, 4, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours 07/28/2016
Buprenorphine HCl Tablet (Sublingual) Develop a dissolution method 09/15/2023
Buprenorphine HCl/Naloxone HCl Film (Sublingual)  V (Paddle over Disk) with 56 mm, 40 mesh stainless steel disk.  100 Acetate Buffer, pH 4.0 (12.5mM Sodium acetate trihydrate and 60mM glacial acetic acid. Adjust the pH with glacial acetic acid or ammonium hydroxide). 900 1, 2, 3, 5, 7 and 10  10/31/2013
Buprenorphine HCl/Naloxone HCl Tablet (Sublingual) Develop a dissolution method 09/15/2023
Bupropion HCl Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Bupropion HCl Tablet (Extended Release) Develop a dissolution method 01/03/2024
Bupropion Hydrobromide Tablet (Extended Release) I (Basket) 75 0.1 N HCl 900 1, 2, 4, 6, 8 and 10 hours 06/10/2009
Buspirone Hydrochloride Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Busulfan Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Busulfan Tablet Develop a dissolution method 09/15/2023
Cabergoline Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Cabotegravir Suspension (Extended Release) II (Paddle) 20 0.5% w/v cetyltrimethylammonium bromide (CTAB) in 140 mM McIlvaine buffer, pH 7.4 1000 5, 10, 20, 30, 45 and 60 07/07/2023
Cabotegravir (CABO); Rilpivirine (RILP) Suspension, Extended release II (Paddle) 20 (CABO); 50 (RILP) 0.5% w/v solution of cetyltrimethylammonium bromide (CTAB) in 140 mM McIlvaine buffer, pH 7.4 (CABO); 6.0% w/v Polysorbate 20 in 0.05 M Sodium Phosphate buffer, pH 7.4 (RILP) 5, 10, 15, 20, 30, 45 and 60 (CABO); 5, 30, 90 and 360 (RILP) 05/18/2023
Cabotegravir Sodium Tablet II (Paddle) 60 0.01N HCl with 0.2% cetyltrimethylammonium bromide (CTAB) 1000 5, 10, 15, 20, 25 and 30  07/07/2022
Cabozantinib S-Malate Capsule  II (Paddle) with sinker  75 0.01 N HCl with 0.5% Triton X-100 (degassed) 900 5, 10, 15, 20 and 30 06/02/2016
Cabozantinib S-Malate Tablet  II (Paddle  75 0.01 N HCl with 0.375% Triton X-100 (degassed) 900 5, 10, 15, 20 and 30 07/28/2016
Caffeine; Ergotamine Tartrate Suppository II (Paddle) 50 1% Tartaric Acid 900 10, 15, 30, 35, 40 and 45 02/05/2024
Calcifediol Capsule (Extended Release)  II (Paddle) with sinker  75 0.5% SDS in 5 mM Sodium Dihydrogenphosphate Monohydrate, pH 6.8 500 1, 2, 4, 6, 8, 10 and 12 hours 10/20/2016
Calcitriol Capsule Develop a quantitative rupture test 06/03/2008
Calcium Acetate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Calcium Acetate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Calcium carbonate/Famotidine/ Magnesium hydroxide Tablet, Chewable III (Reciprocating Cylinder) 0.1 M Sodium Acetate, pH 4.5 900 5,10, 15, 20, 30 and 45 03/30/2023
Canagliflozin Tablet Develop a dissolution method 09/15/2023
Canagliflozin (Can)/ Metformin HCl (Met) Tablet (Extended Release)   Met: I (Basket, 40 mesh): Can: I (Basket, 10 mesh [with option of tablet holder]) Met: 100: Can:100 Met: Simulated Gastric Fluid [SGF] without enzyme, pH 1.2; Can: 0.1% (w/v) polysorbate 20 in 0.05 M sodium phosphate buffer pH 6.8 ( 50 mg); 0.2% (w/v) polysorbate 20 in 0.05 M sodium phosphate buffer pH 6.8 (150 mg) Met: 900: Can: 900 Met: 1, 2, 4, 6, 8 10 and 12 hours: Can: 10, 15, 20, 30, 45 and 60 minutes; 12/22/2016
Canagliflozin/Metformin HCl Tablet II (Paddle) Canagliflozin: 75; Metformin: 50 Canagliflozin (50 mg): 0.025 % Polysorbate 20; Canagliflozin (150 mg):0.075 % Polysorbate 20; Metformin: Phosphate buffer, pH 6.8 Canagliflozin (50 mg): 900; Canagliflozin (150 mg): 900 ; Metformin: 1000 Canagliflozin: 10, 15, 20, 30 and 45; Metformin: 5, 10, 15, 20 and 30 05/28/2015
Candesartan Cilexetil (16 mg, 8 mg and 4 mg) Tablet II (Paddle) 50 0.35% Polysorbate 20 in 0.05 M Phosphate Buffer, pH 6.5 900 10, 20, 30, 45 and 60 06/20/2007
Candesartan Cilexetil (32 mg) Tablet II (Paddle) 50 0.70% Polysorbate 20 in 0.05 M Phosphate Buffer, pH 6.5 900 10, 20, 30, 45 and 60 06/20/2007
Candesartan Cilexetil/Hydrochlorothiazide (16/12.5 mg) Tablet II (Paddle) 50 0.35% Polysorbate 20 in phosphate buffer pH 6.5 900 10, 20, 30, 45 and 60 01/29/2010
Candesartan Cilexetil/Hydrochlorothiazide (32/12.5 mg and 32/25 mg) Tablet II (Paddle) 50 0.70% Polysorbate 20 in phosphate buffer pH 6.5 900 15, 20, 30, 45 and 60 01/29/2010
Capecitabine Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Capmatinib HCl Tablet I (Basket) 75 0.01N HCl (degassed) 900 5, 10, 15, 20, 30 and 45 05/12/2022
Captopril Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Carbamazepine Suspension Develop a dissolution method 09/15/2023
Carbamazepine Capsule (Extended Release)  II (Paddle) 75  First 4 hours: Dilute Acid, pH 1.1. After 4 hours: Phosphate Buffer, pH 7.5 with 0.1% sodium lauryl sulfate (SLS).  First 4 h: 900. After 4 h: 900  1, 2, 4, 6, 8, 10 and 12 hours  09/01/2011
Carbamazepine Tablet  Develop a dissolution method  01/03/2024
Carbamazepine Tablet (Chewable) Develop a dissolution method 09/15/2023
Carbamazepine Tablet (Extended Release) Develop a dissolution method 01/03/2024
Carbidopa Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Carbidopa/Entacapone/Levodopa Tablet I (Basket) Carbidopa and Levodopa: 50; Entacapone: 125 For both Carbidopa and Levodopa: 0.1 N HCl, For Entacapone: Phosphate buffer pH 5.5 Carbidopa and Levodopa: 750 ml. Entacapone: 900 ml 10, 20, 30, 45 and 60 01/03/2007
Carbidopa/Levodopa Tablet (Extended Release)   II (Paddle) 50 0.1 N HCl 900 0.5, 0.75, 1, 1.5, 2, 2.5, 3 and 4 hours   08/15/2013
Carbidopa/Levodopa Suspension (Enteral) II (Paddle) 25 0.05 M Sodium Acetate Buffer, pH 4.5 500 5, 10, 15, 20, 30, 40 and 60 10/20/2016
Carbidopa/Levodopa Capsule (Extended Release) I (Basket)  75 Acid stage: Simulated Gastric Fluid [SGF] without enzyme; Buffer stage: pH 7.0, 50 mM Phosphate Buffer Acid stage: 500 mL [for 23.75/95 mg strength], 900 mL [other strengths]; Buffer stage:500 mL [for 23.75/95 mg strength], 900 mL [other strengths] Acid stage: 30, 60 and 120; Buffer stage: 15, 30, 60, 90, 120, 180 and 240 04/07/2016
Carbidopa/Levodopa Tablet Refer to FDA's Dissolution Guidance, 2018 04/22/2021
Carbidopa/Levodopa Tablet (Orally Disintegrating) II (Paddle) 50 0.1 N HCl 750 5, 10, 15, 30, and 45 07/25/2007
Carbinoxamine Maleate Suspension (Extended Release)  II (Paddle)  50 0.4 M Phosphate Buffer 900 [ 895 mL 0.4 M Buffer +5 mL Suspension] 0.5, 1, 2, 3, 4, 6, 8 and 12 hours 06/02/2016
Carbinoxamine Maleate Tablet Develop a dissolution method 01/03/2024
Carglumic Acid Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Cariprazine HCl Capsule I (Basket)  100 Sodium Acetate Buffer, pH 5.0 (degas) 500 5, 10, 15, 20, 30 and 45 06/30/2016
Carisoprodol Tablet Refer to USP  01/29/2010
Carvedilol Tablet Refer to USP 12/24/2015
Carvedilol Tablet II (Paddle) 50 SGF without enzyme 900 10, 20, 30 and 45 01/21/2004
Carvedilol Phosphate Capsule (Extended Release)  II (Paddle) 100 0.1 N HCl 900 1, 2, 4, 6, 8, 12, 18 and 24 hours  10/31/2013
Carvedilol Phosphate Capsule (Extended Release) II (Paddle) 100 0.1 N HCl 900 1, 4, 8, 12, 18 and 24 hours 04/02/2009
Cedazuridine/Decitabine Tablet II (Paddle) 75 50 mM phosphate buffer, pH 6.8 900 5, 10, 15 and 30  07/07/2022
Cefaclor Capsule Develop a dissolution method 01/03/2024
Cefaclor Tablet (Chewable)  Develop a dissolution method 01/03/2024
Cefaclor Tablet (Extended Release)  Refer to USP 03/03/2011
Cefadroxil Tablet Develop a dissolution method 01/03/2024
Cefadroxil Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Cefadroxil Suspension Develop a dissolution method 09/15/2023
Cefdinir Capsule II (Paddle) 50 Phosphate Buffer, pH 6.8 900 5, 10, 15, 30 and 45 07/25/2007
Cefdinir Suspension II (Paddle) 50 0.05 M Phosphate buffer, pH 6.8 900 10, 20, 30 and 45 04/09/2007
Cefditoren Pivoxil Tablet II (Paddle) 75 Simulated Gastric Fluid without enzyme 900 5, 10, 15, 20 and 30 01/15/2010
Cefixime Tablet (Chewable) II (Paddle 25 Phosphate Buffer, pH 7.2 900 10, 15, 20, 30, and 45 12/23/2010
Cefixime Capsule I (Basket)  100 0.05 M Phosphate Buffer, pH 7.2 900 10, 20, 30, 45 and 60 08/15/2013
Cefixime Suspension II (Paddle) 50 0.05 M Phosphate buffer, pH 7.2 900 10, 20, 30 and 45 04/09/2007
Cefixime Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Cefpodoxime Proxetil Suspension II (Paddle) 50 Glycine Buffer (0.04 M) pH 3.0 900 10, 20, 30 and 45 12/20/2005
Cefpodoxime Proxetil Tablet Refer to USP 07/25/2007
Cefprozil Tablet Develop a dissolution method 01/03/2024
Cefprozil For Oral Suspension Develop a dissolution method 09/15/2023
Cefprozil Monohydrate Suspension Develop a dissolution method 09/15/2023
Ceftibuten Dihydrate Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 7.0 1000 10, 20, 30 and 45 01/21/2004
Cefuroxime Axetil Tablet Refer to USP 07/25/2007
Celecoxib Capsule II (Paddle)  50 mg, 100 mg and 200 mg: 50 rpm; 400 mg: 75 rpm Tier 1 Medium: 0.04 M tribasic sodium phosphate (pH 12) with 1% SLS. Tier 2 Initial Medium: 750 mL of simulated gastric fluid, USP (includes pepsin); At 20 minutes, while stirring, add 180 mL of appropriate concentrations of SLS solution (for a final concentration of 1% SLS). Add about 70 mL of 1.2 N NaOH to adjust the pH to 12. Tier 1: 1000 mL Tier 2: 750 mL (initial) 1000 mL (final) 10, 20, 30, 45 and 60 07/01/2010
Celecoxib; Tramadol HCl Tablet II (Paddle) 75 0.1N Hydrochloric Acid + 2% SLS 1000 5, 10, 15, 20, 30, 45 and 60 07/07/2023
Cenobamate Tablet II (Paddle) 75 0.01N HCl 5, 10, 15, 30, 45, 60 05/12/2022
Cephalexin Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Cephalexin Suspension Develop a dissolution method 09/15/2023
Ceritinib Capsule II (Paddle) 60 0.01 N HCl (degassed) 900 5, 10, 15, 20 and 30 08/27/2015
Ceritinib Tablet I (Basket) 75 0.01 N HCl (degassed) 900 5, 10, 15, 20 and 30 04/22/2021
Cetirizine Capsule (Soft-Gelatin) II (Paddle) 50 25 mM pH 6.8 phosphate buffer 900 5, 10, 15, 20, 30 and 45 01/15/2015
Cetirizine HCl Tablet (Regular & Chewable) Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Cetirizine HCl Tablet (Orally Disintegrating)  Refer to USP 03/17/2016
Cetirizine HCl/Pseudoephedrine HCl Tablet (Extended Release) I (Basket) 100 0.1 N HCl 500 0.17, 0.25, 0.5, 1, 2, 6 and 8 hours 06/18/2007
Cevimeline HCL Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Chlorambucil Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, and 45  08/17/2006
Chlordiazepoxide HCl/ Clidinium Bromide Capsule Develop a dissolution method 01/03/2024
Chlorhexidine Gluconate Tablet (Dental) Develop a method to characterize in vitro release  07/07/2022
Chloroquine Phosphate Tablet Refer to FDA's Dissolution Guidance, 2018 04/16/2020
Chlorothiazide Suspension Develop a dissolution method 03/07/2019
Chlorpheniramine Maleate Tablet (Extended Release) III (Reciprocating Cylinder) 27 dpm Row 1: Test Fluid 1 (0.1N HCl) for 1st hour. Row 2: Test fluid 2 (Phosphate Buffer, pH 7.5) for 5th hour Row 1: 250 mL. Row 2: 250 mL 1 hour for test fluid 1, and 4 hours for test fluid 2 07/25/2007
Chlorpheniramine Maleate/Codeine Phosphate Tablet (Extended Release)   II (Paddle) 50 Simulated gastric fluid (SGF) without enzyme (pH 1.2) 900 0.5, 1, 2, 4, 6, 8 and 12 hours 10/20/2016
Chlorpheniramine Maleate/Ibuprofen/Phenylephrine HCl Tablet II (Paddle) 50 50 mM Potassium Phosphate Buffer, pH 6.5 (degassed) 900 5, 10, 15, 20 and 30 06/25/2015
Chlorpheniramine Maleate/Ibuprofen/Pseudoephedrine HCl Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.5 900 10, 20, 30 and 45 02/20/2004
Chlorpheniramine Polistirex/ Codeine polistirex Suspension (Extended Release) II (Paddle)  50 Acid Stage: 0.1 N HCl; Buffer Stage: pH 6.8 Phosphate Buffer [500 mL 0.1 N HCl for 1 hour, followed by addition of 400 mL of 0.2M NaH2P04 to pH 6.8] Acid Stage: 500 mL; Buffer Stage: 900 mL Acid Stage: 1 hour; Buffer Stage: 1, 2, 4, 6, 8 and 12 hours 03/17/2016
Chlorpheniramine Polistirex/Hydrocodone Polistirex Extended Release Oral Suspension II (Paddle)  50 Simulated Gastric Fluid (SGF) at 37ºC ± 0.5ºC 495 1, 2, 3, 6, 8, 12, 16 and 24 hours 06/30/2011
Chlorpheniramine Polistirex/Hydrocodone Polistirex Capsule (Extended Release) II (Paddle) 50 Simulated Intestinal Fluid without enzyme 500 1, 4, 12, and 24 hours 11/25/2008
Chlorpromazine HCl Tablet  Refer to USP  01/05/2012
Chlorthalidone Tablet Develop a dissolution method 01/03/2024
Chlorzoxazone Tablet Develop a dissolution method 01/03/2024
Cholic Acid Capsule  II (Paddle) with sinker 100 Phosphate Buffer, pH 6.8  500 mL for 50 mg capsule; 900 mL for 250 mg capsule 5, 10, 15, 20 and 30 03/17/2016
Choline Fenofibrate Capsule (Delayed Release) II (Paddle)  50 Acid Stage: 0.05M Sodium Phosphate, pH 3.5 ± 0.05; Buffer Stage: 0.05 M Sodium Phosphate, pH 6.8 ± 0.05 Acid stage: 500; Buffer stage: 900  Acid stage: 120; Buffer stage: 15, 30, 60, 90, 120, 240 and 360  07/01/2010
Ciclopirox Topical Suspension Develop a method to characterize in vitro release  03/25/2010
Cilostazol Tablet Develop a dissolution method 09/15/2023
Cimetidine Tablet Refer to USP 11/30/2023
Cinacalcet HCl Tablet II (Paddle) 75 0.05 N HCl 900 10, 20, 30 and 45 01/26/2006
Ciprofloxacin Oral Suspension II (Paddle)  100 0.05 M Acetate Buffer with 0.025% Brij35 (polyoxyethylene lauryl ether), pH 4.5 900  10, 20, 30 and 45  03/25/2010
Ciprofloxacin Injectable Suspension [Otic] IV (Flow through cell-closed loop) / 22 mm Flow @ 6 mL/min 50 mM Acetate Buffer, pH 4.5 @37°C ± 0.5 [use glass beads; sample volume: 100 μl] 480 5, 10, 15, 20, 30, 45, 60 and 75 03/17/2016
Ciprofloxacin HCl Tablet (Extended Release) I (Basket) 100 0.1 N HCl 900 1, 2, 4, and 7 hours or until at least 80% released 01/14/2008
Ciprofloxacin HCl Tablet Refer to USP  09/02/2010
Ciprofloxacin HCl/Hydrocortisone Otic Suspension Develop a method to characterize in vitro release  09/01/2011
Ciprofloxacin/Ciprofloxacin HCl (AB) Tablet (Extended Release) II (Paddle) 50 0.1 N HCl 900 15, 30, 60, and 120 01/14/2008
Ciprofloxacin/Dexamethasone Otic Suspension Develop a method to characterize in vitro release   03/17/2016
Citalopram Capsule Refer to FDA's Dissolution Guidance, 2018 07/07/2023
Citalopram HBr Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Citalopram Hydrobromide Capsule II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 10/06/2008
Cladribine Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8  (deaerated) 900 5, 10, 15, 20 and 30 05/12/2022
Clarithromycin Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.8 900 10, 20, 30, 45 and 60 01/23/2004
Clarithromycin Tablet (Extended Release) Refer to USP 10/06/2008
Clarithromycin Tablet Refer to USP 07/25/2007
Clindamycin HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Clobazam Film V (Paddle over Disk), with 56 mm, 40 mesh stainless steel disk. 75 0.1 N HCl 900 2, 5, 10, 15, 20 and 30 04/22/2021
Clobazam Tablet II (Paddle) 75 0.1 N HCl (degassed) 900 5, 10, 20, 30, 45 and 60  07/31/2013
Clobazam Oral Suspension II (Paddle) 75 0.1 N HCl (degassed) 900 5, 10, 15, 20, 25 and 30  07/31/2013
Clomiphene Citrate Tablet  Develop a dissolution method 01/03/2024
Clomipramine HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Clonazepam Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Clonazepam Tablet (Orally Disintegrating) Develop a dissolution method 09/15/2023
Clonidine Transdermal Refer to USP  02/18/2009
Clonidine ( 0.1 mg) Tablet (Extended Release)  II (Paddle) with sinker 50 Acid stage: 0.01 N HCl; Buffer stage: Phosphate Buffer, pH 7.0   Acid stage: 500; Buffer stage: 500   Acid stage: 1 and 2 hours; Buffer stage: 1, 2, 4, 6, 10, 14 and 16 hours 01/26/2012
Clonidine ( EQ. 0.17 mg and EQ. 0.26 mg) Tablet (Extended Release)  II (Paddle)  50 500 mL 0.1N HCl for the 1st hour, then add 400 mL 0.27M Sodium Phosphate (Dibasic) buffer solution  Acid stage: 500; Buffer stage: 900   1, 2, 3, 6, 9, 12, 16, 20 and 24 hours  07/01/2010
Clonidine HCl Tablet Refer to USP 06/18/2007
Clonidine HCl (0.1 mg & 0.2 mg) Tablet (Extended Release) II (Paddle) with sinker 50 Acid stage: 0.01 N HCl; Buffer stage: Phosphate Buffer, pH 7.0 Acid stage: 500; Buffer stage: 500 Acid stage: 1 and 2 hours; Buffer stage: 1, 2, 4, 6, 10, 14 and 16 hours 08/27/2015
Clopidogrel Bisulfate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Clorazepate Dipotassium Tablet Refer to USP 01/31/2013
Clotrimazole Tablet (Vaginal) II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 01/24/2004
Clotrimazole Lozenge Refer to USP 10/06/2008
Clozapine Tablet  Refer to USP   07/21/2011
Clozapine Tablet (Orally Disintegrating)  II (Paddle 50 RPM (12.5 mg, 25 mg and 100 mg); 75 RPM (150 mg and 200 mg) pH 4.5 Acetate Buffer 900 5, 10, 15, 20, and 30 06/09/2011
Clozapine Suspension II (Paddle) 50 Acetate Buffer (pH 4.0) 900 5, 10, 15, 20 and 30 05/28/2015
Cobicistat Tablet II (Paddle) 75 50 mM Sodium Acetate Buffer, pH 4.5 900 5, 10, 15, 20 and 30 08/27/2015
Cobicistat (Cobi)/ Darunavir Ethanolate (Drv) Tablet Cobi: II (Paddle): Drv: II (Paddle) Cobi: 75; Drv:75 Cobi: 0.05 M Citrate Phosphate Buffer, pH 4.2; Drv: 0.05 M Sodium Phosphate Buffer, pH 3.0, 2% Tween 20 Cobi: 900 mL; Drv: 900 mL Cobi: 5, 10, 15, 20 and 30; Drv: 10, 15, 20, 30 and 45 10/20/2016
Cobicistat/Elvitegravir/ Emtricitabine/Tenofovir Alafenamide Fumarate Tablet II (Paddle) 100 0.05 M sodium citrate buffer pH 5.5 containing 2.0% w/v polysorbate 80 1000 5, 10, 15, 20 and 30 10/20/2016
Cobicistat/Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate Tablet  II (Paddle) with sinker 100 0.01 N HCl with 2% w/w Polysorbate 80 1000 5, 10, 15, 20 and 30 06/25/2015
Cobimetinib Fumarate Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Codeine Sulfate Tablet  Refer to USP  09/01/2011
Colchicine Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Colchicine Capsule   Develop a dissolution method 09/15/2023
Colesevelam HCl Tablet Disintegration Testing as per USP <701> in various media such as simulated gastric fluid and simulated intestinal fluid. 10/28/2010
Crizotinib Capsule  I (Basket)  100 0.1N HCl (degassed) 900 5, 10, 15, 30 and 45  04/14/2016
Crofelemer Tablet (Delayed Release) II (Paddle)  75 Acid stage: 0.1 N HCl; Buffer stage: Sodium phosphate buffer, pH 6.8 Acid stage: 750; Buffer stage: 1000 Acid stage: 2 hours; Buffer stage: : 5, 10, 20, 30 and 45 minutes 06/02/2016
Cyclobenzaprine Capsule (Extended Release)  Refer to USP  10/20/2016
Cyclobenzaprine HCl Tablet Refer to USP 07/25/2007
Cyclophosphamide Tablet Develop a dissolution method 09/15/2023
Cycloserine Capsule Develop a dissolution method 01/03/2024
Cyclosporine (100 mg) (AB1) Capsule (Liquid filled) II (Paddle) 75 0.1 N HCl containing 4 mg of N,N-dimethydodecylamine-N-oxide per mL 1000 10, 20, 30, 45, 60 and 90 01/14/2008
Cyproheptadine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Cysteamine Bitartrate Capsule (Delayed Release) I (Basket) 75 Acid stage: 0.1N HCl; Buffer stage: 0.05 M Sodium Phosphate buffer, pH 6.8 Acid stage: 1000; Buffer stage: 1000 Acid stage: 2 hours; Buffer stage: : 5, 10, 15, 20 and 30 minutes 08/27/2015
Cysteamine Bitartrate Granule (Delayed Release) I (Basket 75 rpm (for 75 mg strength); 150 rpm (for 300 mg strength) Acid Stage: 0.1 N HCl; Buffer Stage: 0.2M Sodium Phosphate buffer, pH 6.8 Acid Stage: 1000; Buffer Stage:1000 Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30 08/27/2020
Cysteamine Bitartrate Capsule I (Basket) 75 0.1 N HCl 900 10, 20, 30 and 45 01/24/2004
Dabigatran Etexilate Mesylate Capsule I (Basket) for 75 strength: I (Basket with modified diameter of 24.5 mm) for 150 mg strength: 100 0.01 N HCl (pH 2.0) 900 10, 20, 30, and 45  09/22/2011
Dabrafenib Mesylate Capsule II (Paddle) 65 0.2% Cetyl trimethylammonium bromide (CTAB) in 0.1N HCl 900 10, 15, 20, 30 and 45 05/28/2015
Daclatasvir Dihydrochloride Tablet  II (Paddle)  75 Phosphate Buffer, pH 6.8  with 0.75% Brij 35 1000 10, 15, 20, 30 and 45 03/17/2016
Dalfampridine Tablet (Extended Release)  II (Paddle) 50 Phosphate Buffer, pH 6.8 900 0.5, 1, 2, 4, 6, 8, 10 and 12 hours 06/07/2012
Danazol Capsule Refer to USP 06/18/2007
Dantrolene Sodium Capsule I (Basket) 100 0.5% Hyamine 10X in water, adjust to pH 6.8 with 0.1 N KOH or 0.1 N HCl 900 10, 20, 30, 40 and 60 01/27/2004
Dantrolene Sodium For suspension (Intravenous ) II (Paddle) 50 0.5% Benzalkonium Chloride in water 900 0.5, 1, 2, 3, 5 and 10 03/02/2017
Dapagliflozin Propanediol Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Dapagliflozin Propanediol/ Metformin HCl Tablet (Extended Release) I (Basket- 20 mesh) 100 Phosphate Buffer, pH 6.8 1000 Dapagliflozin: 5, 10, 15, 20, 30 and 45 minutes: Metaformin: 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours 08/27/2015
Dapagliflozin/Saxagliptin HCl Tablet Refer to FDA's Dissolution Guidance, 2018 08/27/2020
Dapsone Gel (Topical)  Develop a method to characterize in vitro release  07/28/2016
Dapsone Tablet  Refer to USP  12/23/2010
Daridorexant HCl Tablet II (Paddle) 75 pH 1.2 (NaCl/HCl) 900 5, 10, 15 and 30 05/18/2023
Darifenacin Hydrobromide Tablet (Extended Release) I (Basket) 100 0.01N HCl 900 1, 4, 8, 12, 16, 20 and 24 hours 01/20/2006
Darolutamide Tablet II (Paddle) 75 1% sodium lauryl sulfate (SLS) in 0.01N HCl 1000 15, 30, 45, 60, 75 and 90 01/30/2020
Darunavir Ethanolate Oral Suspension II (Paddle) 75 0.05% Polysorbate 20 in 0.05M Phosphate Buffer, pH 6.8 900 5, 10, 15, 20, 30 and 45 06/25/2015
Darunavir Ethanolate Tablet II (Paddle) 75 2% Tween-20 in 0.05 M Sodium Phosphate Buffer, pH 3.0 900 10, 20, 30, and 45  09/13/2007
Darunavir(Drv)/Cobicistat (Cobi)/Emtricitabine (Emt)/Tenofovir Alafenamide Fumarate (Taf) Tablet II (Paddle) 75 Drv: 0.05 M Sodium Phosphate Buffer, pH 3.0, 2% Tween 20; For Cobi, Emt and Taf: Citrate Phosphate Buffer, pH 4.2 900 Drv: 10, 15, 20, 30 and 45; For Cobi, Emt and Taf: 5, 10, 15, 20 and 30 07/07/2022
Dasabuvir Na/ Ombitasvir/Paritaprevir/Ritonavir Tablet (Extended Release)   III (Reciprocating Cylinder [40 mesh (for bottom and top of the inner tube)] 25 dpm 15 mM hexadecyltrimethylammonium bromide (CTAB) in 0.03M Sodium Phosphate Buffer, pH 6.8 250 Ombitasvir/ Paritaprevir/ Ritonavir: 10, 15, 20, 30, 45, 60 and 90 minutes;Dasabuvir: 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24 hours 10/20/2016
Dasatinib Tablet II (Paddle) 60 pH 4.0 Acetate buffer containing 1% Triton X-100 1000 10, 15, 30 and 45 10/30/2009
Deferasirox Granule II (Paddle) 75 Phosphate Buffer, pH 6.8 with 0.5% Tween 20 900 5, 10, 15, 20 and 30 11/02/2017
Deferasirox Tablet  II (Paddle)  75 0.5% Tween 20 in Phosphate Buffer, pH 6.8  900 5, 10, 15, 20 and 30 03/17/2016
Deferasirox Tablet (for Oral Suspension) II (Paddle) 50 Phosphate buffer pH 6.8 with 0.5% Tween 20 900 10, 20, 30 and 45 06/21/2006
Deferiprone Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Deferiprone (1 GM) Tablet I (Basket) 100 Acidic Stage: 0.1 N HCl, Buffer Stage: 0.05 M Phosphate buffer, pH 6.8. Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours 07/07/2022
Deflazacort Suspension II (Paddle) 25 Simulated Gastric Fluid, pH 1.2 500 5, 10, 15 and 30 07/07/2023
Deflazacort Tablet II (Paddle) 50 50 mM Phosphate buffer w/0.3% SLS, pH 6.8 500 5, ,15, 30 and 45 07/07/2023
Degarelix Acetate Powder for Injection Develop a method to characterize in vitro release 10/06/2023
Delafloxacin Meglumine Tablet II (Paddle) 60 0.05 M Phosphate Buffer, pH 7.4 (degassed) 900 5, 10, 15, 20 and 30 11/16/2017
Delavirdine Mesylate Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.0 containing 0.6% w/v SDS 900 10, 20, 30, 45 and 60 12/03/2007
Demeclocycline HCl Capsule Develop a dissolution method 01/03/2024
Demeclocycline HCl Tablet Develop a dissolution method 01/03/2024
Desipramine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Desloratadine Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Desloratadine Tablet (Orally Disintegrating) II (Paddle) 50 0.1 N HCl 900 3, 6, 10, 15 06/18/2007
Desloratadine/Pseudoephedrine Sulfate (2.5 mg/120 mg) Tablet (Extended Release) II (Paddle) 50 First hour: 0.1 N HCl; After 1 hour: 0.1M Potassium Phosphate Buffer pH 7.5 1000 For Desloratadine: 10, 20, 30 and 45; For Pseudoephedrine Sulfate: 1, 2, 6 and 8 hours 04/02/2009
Desloratadine/Pseudoephedrine Sulfate (5 mg/240 mg) Tablet (Extended Release) II (Paddle) 50 First hour: 0.1 N HCl; After 1 hour: 0.1M Potassium Phosphate Buffer pH 7.5 1000 For Desloratadine: 10, 20, 30 and 45; For Pseudoephedrine Sulfate: 1, 2, 4, 8, 16 and 24 hours 04/02/2009
Desmopressin Acetate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Desogestrel/Ethinyl Estradiol Tablet Refer to USP 11/04/2008
Desvenlafaxine Succinate Tablet (Extended Release) Develop a dissolution method 09/15/2023
Deucravacitinib Tablet II (Paddle) 75 50 mM potassium phosphate buffer, pH 6.3 with 0.01% (w/v) Brij®35 1000 10, 20, 30, 45 and 60 11/30/2023
Deutetrabenazine Tablet II (Paddle) over a disk (62 mm with 16 mesh) 75 pH 3.0 Acid Phthalate Buffer 500 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours 11/02/2017
Dexamethasone Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Dexamethasone Implant (Intravitreal) VII (with reciprocating 50 mesh baskets) 30 cycles per min  Phosphate Buffered Saline containing 0.05 g/L sodium dodecyl sulfate at 45 ± 0.5°C 30 12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hours 10/21/2010
Dexamethasone/Neomycin Sulfate/ Polymyxin B Sulfate Ophthalmic Suspension Develop a method to characterize in vitro release 02/15/2018
Dexamethasone/Tobramycin Ophthalmic Suspension Develop a method to characterize in vitro release 04/02/2009
Dexbrompheniramine Maleate/Pseudoephedrine Sulfate Tablet (Extended Release) III (Reciprocating Cylinder) 12 dpm 0.02N HCl (2 hours) followed by 0.05M Phosphate Buffer pH 7.5 250 0.5, 1, 2, 3, 4, 6 and 8 hours 05/28/2015
Dexlansoprazole Tablet (Delayed Release, Orally Disintegrating) I (Basket -100 mesh) 100 Acid Stage: 0.1 N HCl; Buffer Stage: pH 7.2 Phosphate Buffer with 5 mM Sodium lauryl sulfate Acid Stage: 500 mL; Buffer Stage: 900 mL Acid Stage: 120; Buffer Stage: 10, 15, 20, 30, 50, 60, 75 and 90  07/28/2016
Dexlansoprazole Capsule (Delayed Release) I (Basket) 100 Acid Stage: 0.1 N HCl, Buffer Stage: pH 7.0 Phosphate Buffer with 5 mM SLS Acid Stage: 500; Buffer stage: 900 Acid Stage: 120; Buffer Stage: 10, 20, 40, 50, 60 , 75, 105 and 120 08/05/2010
Dexmedetomidine HCl Sublingual Film V (Paddle over disk) 50 Simulated saliva 500 5, 10, 15, 20 and 30 05/31/2023
Dexmethylphenidate HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Dexmethylphenidate HCl Capsule (Extended Release) I (Basket) 100 First 2 hours: 0.01 N HCl, Hours 2-10: Phosphate Buffer, pH 6.8 Acid: 500, Buffer: 500 0.5, 1, 2, 4, 6, and 10 hours 01/14/2008
Dexmethylphenidate HCl; Serdexmethylphenidate Chloride Capsule Refer to FDA's Dissolution Guidance, 2018 05/18/2023
Dextroamphetamine Transdermal System VI (Cylinder) 50 50 mM potassium phosphate buffer, pH 6.8 5, 10, 15, 30, 45, 60, 120, 180, 240, 300 and 360 11/30/2023
Dextroamphetamine Sulfate Capsule (Extended Release) I ( Basket) 100 0.1 N HCl 500 1, 4, 8 and 12 hours 11/25/2008
Dextroamphetamine Sulfate Tablet Develop a dissolution method 09/15/2023
Dextroamphetamine Sulfate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Dextromethophan HBr/Guaifenesin Tablet (Extended Release) I (Basket) 50 0.01 N HCl 900 1, 2, 6, and 12 hours 11/25/2008
Dextromethorphan Hydrobromide/Quinidine Sulfate Capsule I (Basket) 100 pH 1.2, Simulated Gastric Fluid without enzyme 900 5, 10, 15, 20 and 30 01/05/2012
Dextromethorphan Polistirex Suspension (Extended Release) II (Paddle) 50 0.1 N HCl 500 30, 60, 90 and 180 10/06/2008
Diazepam Tablet Refer to USP 07/25/2007
Diazoxide Oral suspension Develop a dissolution method    02/14/2014
Diclofenac Capsule I (Basket) 100 10 mM Citrate Buffer pH 5.5 with 0.05% Sodium Dodecyl Sulfate (SDS) 900 5, 10, 20, 30 and 45 06/25/2015
Diclofenac Epolamine Topical patch V (Paddle over Disk) with a watchdish (a diameter of 6 cm) 50 pH 6.8 phosphate buffer at 32 ± 0.5°C 500 15, 30, 45, 60, 90, 120 and 180 10/21/2010
Diclofenac Potassium Powder for Oral Solution II (Paddle 75 0.05M phosphate buffer (TriSodium Phosphate Dodecahydrate in 0.1 N HCl and pH adjusted to 6.8) 400 2.5, 5, 7.5 and 10 10/21/2010
Diclofenac Potassium Capsule II (Paddle 50 50 mM Phosphate buffer pH 6.8 900 10, 15, 20, 30 and 45  10/21/2010
Diclofenac Potassium Tablet II (Paddle) 50 SIF without enzyme 900 10, 20, 30, 45, 60 and 90 01/27/2004
Diclofenac Sodium Tablet (Extended Release) Refer to USP 06/10/2009
Diclofenac Sodium Tablet (Delayed Release) Refer to USP 06/10/2009
Diclofenac Sodium/Misoprostol Enteric Coated Tablet (Delayed Release) II (Paddle) (diclo) 100 (diclo) Diclofenac: Acid Stage: 0.1 N HCl Buffer Stage: 750ml 0.1N HCL+250ml 0.2M phos.buffer, pH 6.8 (Method A) Misoprostol: Develop a dissolution method Diclo: Acid: 750 Buffer:1000 Diclo.: 120 (acid) 15, 30, 45 and 60 (Buffer) 09/15/2023
Dicloxacillin Sodium Capsule Develop a dissolution method 01/03/2024
Dicyclomine Hydrochloride Tablet Refer to USP 05/12/2022
Didanosine Tablet (Chewable) Develop a dissolution method 09/15/2023
Didanosine Capsule (Delayed Release Pellets) I (Basket) 100 Acid stage: 0.1 N HCl; Buffer stage: 0.1 N HCl:0.2M Tribasic Sodium Phosphate (3:1), pH 6.8 1000 Acid stage: 60, 90 and 120; Buffer stage: 10, 20, 30, 45 and 60 01/26/2004
Dienogest/Estradiol Valerate Tablet Develop a dissolution method 09/15/2023
Diethylpropion HCl Tablet (Extended Release) Develop a dissolution method 09/15/2023
Diflunisal Tablet Refer to USP 04/15/2008
Digoxin Tablet Refer to USP 06/18/2007
Diltiazem HCl Tablet (Extended Release) II (Paddle) 100 Phosphate Buffer, pH 5.8 900 2, 8, 14, and 24 hours 02/19/2008
Diltiazem HCl Capsule (Extended Release) Develop a dissolution method 01/03/2024
Dimethyl Fumarate Capsule  (Delayed Release) II (Paddle)  100 Acid stage: 0.1 N HCl; Buffer stage: pH 6.8 Phosphate Buffer Acid stage: 500; Buffer stage: 500 Acid stage: 2 hours; Buffer stage: 5, 10, 20, 30 and 45 06/02/2016
Dinoprostone Vaginal Suppository Develop a method to characterize in vitro release    10/04/2012
Dinoprostone Vaginal Insert (Extended Release) Develop a dissolution method 09/15/2023
Diphenhydramine Citrate/Ibuprofen Tablet II (Paddle) 50 50 mM Phosphate Buffer, pH 6.5 900 10, 20, 30 and 45 01/14/2008
Diphenhydramine HCl/Ibuprofen Capsule I (Basket) 100 200 mM Phosphate Buffer, pH 7.2 900 10, 20, 30 and 45 01/14/2008
Dipyridamole Tablet Refer to USP 06/18/2007
Diroximel Fumarate Capsule (Delayed Release) II (Paddle) with sinker 75 Acid Stage: 0.1 N HCl; Buffer Stage: Na.Phosphate Buffer, pH 6.5   Acid Stage: 120; Buffer Stage: 10, 20, 30, 45, 60, 75 and 90 04/02/2020
Disopyramide Phosphate Capsule (Extended Release) Refer to USP 11/04/2008
Disopyramide Phosphate Capsule Develop a dissolution method 01/03/2024
Disulfiram Tablet II (Paddle) 100 2% SDS 900 15, 30, 45, 60, 75, 90, 105, and 120 06/18/2007
Divalproex Sodium Tablet (Delayed Release) Refer to USP 07/25/2007
Divalproex Sodium Tablet (Extended Release)   Refer to USP  06/30/2016
Divalproex Sodium Capsule (Delayed Release)  Refer to USP  06/30/2016
Dofetilide Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Dolasetron Mesylate Tablet Develop a dissolution method 01/03/2024
Dolutegravir Na/Rilpivirine HCl Tablet II (Paddle) 75 1.0 % Tween 20 in 0.01 M HCl, pH 2.0 900 10, 15, 20, 30, 45 and 60 02/08/2018
Dolutegravir Sodium (10 mg) Tablet II (Paddle) 50 0.01M pH 6.8 phosphate buffer 900 5, 10, 15, 20, 30 and 45 10/18/2018
Dolutegravir Sodium (25 mg) Tablet II (Paddle) 50 0.01M pH 6.8 phosphate buffer containing 0.15% w/v sodium dodecyl sulfate (SDS) 900 5, 10, 15, 20, 30 and 45 10/18/2018
Dolutegravir Sodium (50 mg) Tablet II (Paddle) 50 0.01M pH 6.8 phosphate buffer containing 0.25% w/v sodium dodecyl sulfate (SDS) 900 5, 10, 15, 20, 30 and 45 10/18/2018
Donepezil HCl/Memantine HCl Capsule (Extended Release) I (Basket) 100 pH 1.2 NaCl/HCl buffer 900 Donepezil: 5, 10, 15, 20 and 30 minutes; Memantine: 1, 2, 3, 4, 6, 8, 10 and 12 hours 05/28/2015
Donepezil HCl Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Donepezil HCl Tablet (Orally Disintegrating (ODT)) II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 03/04/2006
Donepezil HCl Transdermal V (Paddle over disk) with Transdermal System Holding Wire Screen (TSHWR) 100 0.02 M sodium acetate buffer, pH 4.5 at 32°C 900 1,8,24,48 and 168 hours 05/18/2023
Donepezil HCl (23 mg) Tablet  II (Paddle 50 0.05 M Phosphate Buffer, pH 6.8 900 1, 2, 3, 4, 6, 8 and 10 hours 12/23/2010
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Tablets II (Paddle) 75 25 mM Phosphate Buffer, pH 6.8 with 3% Polysorbate 80 900 5, 10, 15, 20, 30, 45, 60 and 90 10/06/2023
Doxazosin Mesylate Tablet (Extended Release) II (Paddle) 75 SGF without enzyme 900 1, 2, 4, 6, 8, 12 and 16 hours 01/03/2007
Doxazosin Mesylate Tablet II (Paddle) 50 0.01 N HCl 900 10, 20, 30, 45 and 60 01/27/2004
Doxepin HCl Tablet II (Paddle) 50 Simulated Gastric Fluid w/o enzyme (pH 1.1-1.3) 900 5, 10, 15, 20, 30 and 45  09/02/2010
Doxepin HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Doxepin HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Doxercalciferol Capsule Develop a quantitative rupture test 06/03/2008
Doxorubicin HCl Injectable (Liposomal)  Develop a method to characterize in vitro release, starting at pH 6.00 ± 0.05 and at 47ºC ± 0.5ºC. Replicate for 12 dosage vials. 10/04/2012
Doxycycline Capsule (Delayed Release) II (Paddle) 75 Dilute HCl, pH 1.1 for 2 hours and then add 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 6.0 using 2 N HCl and/or 2N NaOH Acid stage: 750; Buffer stage: 950 1, 2, 2.5 , 3 and 4 hours 10/06/2008
Doxycycline Suspension II (Paddle) 25 0.01 N HCl 900 5, 10, 15 and 20 09/03/2008
Doxycycline Calcium Suspension   Develop a dissolution method 03/07/2019
Doxycycline Hyclate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Doxycycline Hyclate Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Doxycycline Hyclate ( 120 mg and 60 mg) Tablet (Delayed Release)  I (Basket) 100 Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5  Acid stage: 900 mL; Buffer stage: 900 mL Acid stage: 10, 20, 30, 45 and 60; Buffer stage: 5, 10, 15, 20, 30 and 45 03/27/2018
Doxycycline Hyclate ( 150 mg and 75 mg) Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Doxycycline Hyclate ( 200 mg, 150 mg, 100 mg, 80 mg and 75 mg) Tablet (Delayed Release) Refer to USP 05/28/2015
Doxycycline Hyclate ( 50 mg) Tablet (Delayed Release) I (Basket) 100 Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5 900 Acid stage: 5, 10, 15, 20 and 30; Buffer stage: 5, 10, 15, 20 and 30 05/28/2015
Doxylamine Succinate/Pyridoxine HCl Tablet (Extended Release)   II (Paddle) 100 Acid stage: 0.1 N HCl: Buffer stage: 0.2M sodium phosphate buffer pH 6.8 Acid stage: 1000 mL; Buffer stage: 1000 mL Acid stage: 5, 10, 15, 30, 60, 120; Buffer stage: 5, 10, 15, 20 and 30 01/19/2017
Dronabinol Capsule Develop a dissolution method; (In addition, the USP capsule rupture test should also be conducted) 09/15/2023
Dronedarone HCl Tablet II (Paddle) with sinker 75 pH 4.5 Phosphate buffer 1000 10, 15, 20, 30, 45, 60, 90 and 120 02/25/2015
Drospirenone/Estetrol Tablet II (Paddle) 50 Phosphate Buffer pH 6.8 900 5,10, 15, 20 and 30 03/30/2023
Drospirenone/Estradiol Tablet Develop a dissolution method 09/15/2023
Drospirenone/Ethinyl Estradiol Tablet  Develop a dissolution method 01/03/2024
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Tablet  II (Paddle) 50 Phosphate buffer pH 6.8, saline with 0.03 % ascorbic acid 900 5, 10, 15, 20 and 30 07/28/2016
Droxidopa Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Duetetrabenazine Tablet, Extended Release II (Paddle) with sinker 75 50 mM potassium biphthalate buffer, pH 3.0 500 2, 4, 6, 8, 10, 12. 16 and 20 hours 11/30/2023
Duloxetine HCl Capsule (Delayed Release)  Refer to USP 03/17/2016
Dutasteride Capsule (Soft-Gelatin) II (Paddle)  50 Tier I: Dissolution Medium: 0.1 N HCI with 2% (w/v) sodium dodecyl sulfate (SDS) (900 mL) Tier II: Dissolution Medium: 0.1 N HCI with pepsin (as per USP) (450 mL) for the first 25 minutes, followed by addition of 0.1 N HCI with SDS (4% w/v) (450 mL) for the remainder of the dissolution test.  900  15, 30, 45 and 60  08/05/2010
Dutasteride/Tamsulosin HCl Capsule Dutasteride: II (Paddle) with sinker. Tamsulosin: II (Paddle) Dutasteride: 75 Tamsulosin: 50 Dutasteride::Tier I: Dissolution Medium: 1%w/v cetyltrimethylammonium bromide (CTAB) in 0.1 N HCl. Tier II: Dissolution Medium: 1% w/v CTAB in 0.1 N HCl with 0.16% w/v pepsin. Tamsulosin:: Acid Stage (0-2 hrs): 0.1 N HCl. Buffer stage: Add 250 mL of 0.2 M Sodium Phosphate Tribasic, Dodecahydrate pH 6.8 Dutasteride: 900. Tamsulosin: Acid stage: 750; Buffer stage: 1000 Dutasteride: 15, 30, 45 and 60 minutes. Tamsulosin: Acid Stage: 2 hours Buffer stage: 0.5, 1, 2, 3, 5, 7 and 10 hours 01/26/2012
Edaravone Suspension II (Paddle) 75 pH 4.0 Acetate Buffer 900 5, 10, 15, 20 and 30 07/28/2022
Efavirenz Capsule Develop a dissolution method 09/15/2023
Efavirenz Tablet Develop a dissolution method 09/15/2023
Efavirenz 600 mg; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg Tablet Develop a dissolution method 09/15/2023
Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate Tablet Develop a dissolution method 09/15/2023
Elagolix Sodium Tablet II (Paddle) 50 0.05 M Sodium Phosphate, pH 6.8 900 5, 10, 15, 20, 30 and 45 04/22/2021
Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium Capsule Elagolix: I (Basket) Elagolix: 100 Elagolix: 0.05M Sodium Phosphate pH 6.8 10, 15, 20, 25, 30, 45, 60 and 90 02/05/2024
Elbasvir/Grazoprevir Tablet  I (Basket) 100 Phosphate Buffer, pH 6.8 with 0.45% (w/v) Polysorbate 80 900 10, 15, 20, 30, 45 and 60 07/28/2016
Eletriptan Hydrobromide Tablet I (Basket) 100 0.1 N HCl 900 5, 10, 15 and 30 04/02/2009
Elexacaftor, Ivacaftor, Tezacaftor [FDC:ELE+ IVA+ TEZ]; Ivacaftor [IVA] Tablet/Tablet (Copackage) II (Paddle) FDC: ELE: 75/IVA: 65/TEZ:75; IVA: 75 FDA: ELE: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8/ IVA: 0.4% (w/v) SLS in 50 mM sodium phosphate, pH 6.8/TEZ: 0.2% (w/v) SLS solution in 0.1N HCl; IVA: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8 FDC: ELE: 900/IVA: 900/TEZ:900; IVA 900 5, 10, 15, 20 and 30 08/19/2021
Eliglustat Tartrate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Eltrombopag Olamine Suspension II (Paddle) 50 50 mM potassium phosphate in water, pH 6.8 with 0.2% polysorbate 80 750 4, 8, 12, 15 and 20 10/20/2016
Eltrombopag Olamine Tablet II (Paddle) 50 0.5% Polysorbate 80 in Phosphate Buffer, pH 6.8  900 10, 15, 20, 30, 45, and 60  06/07/2012
Eluxadoline Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Elvitegravir Tablet II (Paddle) with sinker 75 2.0% w/v Polysorbate 80 in 0.01 N HCl (pH 2.0) at 37 ºC 700 mL for 85 mg tablets; 1000 mL for 150 mg tablets 1000 mL for 150 mg tablets 10, 20, 30, 45 and 60 12/24/2015
Empagliflozin Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Empagliflozin/ Metformin HCl Tablet (Extended Release)   I (Basket) 100 Phosphate Buffer, pH 6.8 900 Metformin: 1, 2, 4, 6, 8, 10 and 12 hours: Empagliflozin: 10, 15, 20, 30, 45 and 60 minutes; 01/19/2017
Empagliflozin/Linagliptin Tablet II (Paddle) 50 pH 6.8 Phosphate Buffer 900 10, 15, 20, 30 and 45 12/24/2015
Empagliflozin/Linagliptin/Metformin HCl Tablet (Extended Release) I (Basket) 100 Phosphate Buffer, pH 6.8 900 Metformin: 1, 2, 4, 6, 8, 10 and 12 hours: Empagliflozin and Linagliptin: 10, 15, 20, 30, 45 and 60 minutes 04/02/2020
Empagliflozin/Metformin HCl Tablet  II (Paddle) 50 Phosphate Buffer, pH 6.8 (degas) 900 5, 10, 15, 20 and 30 06/30/2016
Emtricitabine Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Emtricitabine/Rilpivirine HCl/Tenofovir Alafenamide Fumarate Tablet  II (Paddle  75 Rilpivirine (RPV): 0.5% Polysorbate 20 in 0.01 N HCl; Emtricitabine (ETC) and Tenofovir alafenamide (TAF): 50 mM Sodium Citrate, pH 5.5, RPV: 1000 mL; ETC and TAF: 500 mL 5, 10, 15, 20, 30 and 45 07/28/2016
Emtricitabine/Rilpivirine HCl/Tenofovir Disoproxil Fumarate Tablet  II (Paddle) with sinker 75 0.5%(w/w) polysorbate 20 in 0.01N HCl (pH 2.0) 1000 Emtricitabine and Tenofovir: 5, 10, 15, 20 and 30; Rilpivirine: 10, 20, 30, 45, 60, 75, 90 and 120 01/15/2015
Emtricitabine/Tenofovir Alafenamide Fumarate Tablet  II (Paddle  75 50 mM Sodium Citrate buffer, pH 5.5 500 5, 10, 15, 20, 30 and 45 07/28/2016
Emtricitabine/Tenofovir Disoproxil Fumarate Tablet II (Paddle) 50 0.01 N HCl 900 5, 10, 15, 30 and 45 01/03/2007
Enalapril Maleate Tablet Refer to USP 09/03/2008
Entacapone Tablet II (Paddle) 50 Phosphate Buffer, pH 5.5 900 10, 20, 30 and 45 01/29/2004
Entecavir Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Entrectinib Capsule II (Paddle) with Sinker 75 50 mM Potassium Phosphate, pH 6.0 with 0.374% w/v polysorbate 80 1000 15, 20, 30, 45, 60 and 75 08/19/2021
Enzalutamide Capsule II (Paddle) with sinker 50 Tier 1 Medium: 0.3% cetyl trimethyl ammonium bromide (CTAB) in 0.1 N HCl;Tier 2 Medium: 0.3% CTAB in 0.1 N HCl containing Pepsin 600,000 USP units/L. 900 10, 15, 20, 30 and 45 05/28/2015
Enzalutamide Tablet II (Paddle) 50 Phosphate Buffer, pH 7.5 900 5, 10, 15, 20, 30 and 45 05/12/2022
Eplerenone Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Eprosartan Mesylate Tablet II (Paddle) 75 0.2 M Phosphate Buffer, pH 7.5 1000 15, 30, 45 and 60 07/14/2008
Eprosartan Mesylate/Hydrochlorothiazide Tablet II (Paddle) 75 0.2 M Phosphate Buffer, pH 7.5 1000 10, 20, 30 and 45 02/19/2008
Ergocalciferol Capsule II (Paddle) 100 0.5 N NaOH with 10% Triton-X-100 500 15, 30, 45, 60 and 90 08/05/2010
Erlotinib HCl Tablet II (Paddle) 75 0.02% Tween 80 in 0.01 N HCl 1000 5, 10, 15, 20, 30 and 45 10/18/2018
Erythromycin Tablet Refer to USP 12/24/2015
Erythromycin Tablet (Delayed Release)  Refer to USP 10/31/2013
Erythromycin Ethylsuccinate Suspension II (Paddle) 75 Monobasic Sodium Phosphate, pH 6.8 Buffer with 1% SLS Buffer w/ 1% SLS 900 10, 20, 30, 45 and 60 01/27/2004
Erythromycin Ethylsuccinate Tablet Refer to USP 04/22/2021
Erythromycin Ethylsuccinate Oral granule Develop a dissolution method    06/30/2016
Erythromycin Ethylsuccinate/Sulfisoxazole Acetyl Granules for Oral Suspension Develop a dissolution method   09/02/2010
Escitalopram Oxalate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Escitalopram Oxalate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Eslicarbazepine Acetate Tablet II (Paddle) 100 Acetate Buffer, pH 4.5 1000 5, 10, 15, 20, 30 and 45 08/27/2015
Esomeprazole Magnesium Capsule (Delayed Release Pellets) Refer to USP 08/27/2015
Esomeprazole Magnesium Tablet (Orally Disintegrating, Delayed Release) II (Paddle) Acid stage: 100; Buffer stage: 75 Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 6.8 Acid stage: 300; Buffer stage: 1000  Acid stage: 120; Buffer stage: 5, 10, 20, 30 and 45 04/22/2021
Esomeprazole Magnesium Tablet (Delayed Release)  II (Paddle) 100 Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 6.8 Acid stage: 300; Buffer stage: 1000   Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60   10/20/2016
Esomeprazole Magnesium For Oral Suspension (Delayed Release) II (Paddle 100 Acid stage: 0.1 N HCl; Buffer stage: Sodium Phosphate Buffer, pH 6.8  Acid stage: 300; Buffer stage: 1000  Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60  09/02/2010
Estazolam Tablet Develop a dissolution method 09/15/2023
Esterified Estrogens Tablet Develop a dissolution method 09/15/2023
Estradiol Vaginal Ring Incubator shaker 130 0.9% Saline 250 1, 9, 16, 17, 18, 19, 45 days 01/03/2007
Estradiol Vaginal Tablet I (Basket) 40 Phosphate Buffer, pH 4.75 ± 0.05 500 1, 2, 3, 5, 8, 10 and 12 hours 07/21/2009
Estradiol (0.014 mg/24 hr) Film, Transdermal (Extended Release)  Develop a method to characterize in vitro release   10/28/2010
Estradiol (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.06 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) Film, Transdermal (Extended Release)  Develop a method to characterize in vitro release   10/28/2010
Estradiol (Test 1) (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) Film, Transdermal (Extended Release)  VI (Cylinder) attach the patch to a disk at the bottom of the cylinder 50 Water at 32 ± 0.5°C 0.025 mg/24 hr and 0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL 1, 2, 4, 6, 8, 10 and 12 hours 10/28/2010
Estradiol (Test 2) (0.05 mg/24 hr and 0.1 mg/24 hr) Film, Transdermal (Extended Release)  V (Paddle over Disk) with a stainless steel disk 50 Water at 32 ± 0.5°C 900 6, 12, 18, 24, 36, 48, 60, 72 and 96 hours 10/28/2010
Estradiol (Test 3) 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr)  Film, Transdermal (Extended Release)  VI (Cylinder) attach the patch to the cylinder with double-sided tape 50 Water at 32 ± 0.5°C 0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL  1, 2, 4, 6, 10, 12, 18, 24 and 36 hours  10/31/2013
Estradiol/Levonorgestrel Film, Transdermal (Extended Release) V (Paddle over Disk) attach the patch to the stainless steel plate with double-sided tape 50 30% Ethanol in water at 32±0.5°C 660 30, 60, 120, 180, 240 and 300 03/30/2023
Estradiol/Norethindrone Acetate Film, Transdermal (Extended Release) V (Paddle over Disk) 50 0.24% SDS in water at 32±0.5°C 0.05 mg/0.14 mg/24 hr: 500; 0.05mg/0.25 mg/24 hr: 900 1, 2, 4, 8, 12 and 14 hours 03/30/2023
Estradiol/Norethindrone Acetate Tablet  Develop a dissolution method 01/03/2024
Estradiol/Norgestimate (1mg/0.09mg) Tablet Develop a dissolution method 09/15/2023
Estradiol/Progesterone Capsule III (Reciprocating Cylinder) [40 mesh for bottom and top of the inner tube] 3% sodium lauryl sulfate (SLS) in 0.1N HCl 250 10, 20, 30, 45 and 60 01/30/2020
Estramustine Phosphate Sodium Capsule Develop a dissolution method 09/15/2023
Estrogens Conjugated Synthetic A Tablet Develop a dissolution method 09/15/2023
Estrogens, Conjugated (EC)/Medroxyprogesterone Acetate (MPA) Tablet II (Paddle) with sinker 50 EC: 0.02 M Na Acetate Buffer (pH 4.5); MPA: Develop a dissolution method 900 09/15/2023
Estrogens, Conjugated Synthetic B Tablet Develop a dissolution method 09/15/2023
Eszopiclone Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Ethacrynic Acid Tablet  Refer to USP  12/23/2010
Ethambutol HCl Tablet Develop a dissolution method 01/03/2024
Ethinyl Estradiol Tablet  Refer to USP  09/22/2011
Ethinyl Estradiol/Ethynodiol Diacetate Tablet Develop a dissolution method 09/15/2023
Ethinyl Estradiol/Etonogestrel Vaginal Ring Develop a method to characterize in vitro release  01/31/2013
Ethinyl Estradiol/Levonorgestrel Transdermal System V (paddle over disk) 75 0.25% Hydroxypropyl-Beta-Cyclodextrin (HPCD) in Water (Deaerated ), 32±0.5˚C 500 1, 2, 4, 6, 12, 24, 36, 48, 72 and 96 hours 05/12/2022
Ethinyl Estradiol/Levonorgestrel Tablet Develop a dissolution method 01/03/2024
Ethinyl Estradiol/Norethindrone Tablet (Chewable) II (Paddle) 75 0.09% Sodium Lauryl Sulfate in 0.1 N HCl 500 10, 15, 20, 30 and 45  01/14/2008
Ethinyl Estradiol/Norethindrone Tablet Refer to USP 07/15/2009
Ethinyl Estradiol/Norethindrone Acetate Tablet Refer to USP 07/15/2009
Ethinyl Estradiol/Norethindrone Acetate Capsule II (Paddle) 100 Phosphate Buffer, pH 6.8, containing 0.07% w/v Triton X 100 900 5, 10, 20, 30, 45, 60 and 75 02/15/2018
Ethinyl Estradiol/Norethindrone Acetate [0.01mg,0.01 mg;1 mg] Tablet (Chewable) II (Paddle) 75 0.025 M Na Acetate Buffer with 0.15% Sodium Lauryl Sulfate [SLS] (pH 5.0) [degassed] 500 10, 15, 20, 30 and 45 12/24/2015
Ethinyl Estradiol/Norethindrone Acetate [0.02mg;1mg] Tablet (Chewable) II (Paddle)  75 0.025 M Sodium Acetate Buffer with 0.15% SLS, pH 5.0 600 10, 15, 20, 30 and 45  02/14/2014
Ethinyl Estradiol/Norgestimate Tablet Develop a dissolution method 09/15/2023
Ethinyl Estradiol/Norgestimate (AB) Tablet Develop a dissolution method 09/15/2023
Ethinyl Estradiol/Norgestrel Tablet Develop a dissolution method 09/15/2023
Ethinyl Estradiol; Norelgestromin Film, Transdermal Modified USP Type V (Paddle-over-disk) 50 0.1% Hydroxypropyl-beta-cyclodextrin at 32º C 900 0.25, 0.5, 1, 2, 4, 8, 12, 16, 20 and 24 hours 05/20/2009
Ethionamide Tablet I (Basket) 75 0.1 N HCl 900 10, 20, 30, 45 and 60  01/31/2013
Ethosuximide Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Etidronate Disodium Tablet Develop a dissolution method 01/03/2024
Etodolac Tablet Refer to USP 01/14/2008
Etodolac Tablet (Extended Release)  Refer to USP 06/24/2010
Etoposide Capsule Refer to USP 06/24/2010
Etravirine (200 mg) Tablet  II (Paddle)  70 1.0 % Sodium lauryl sulfate (SLS) in 0.01 M HCl in two phases: Phase 1: 1000 mL of degassed 0.01 M HCl for 10 minutes. Phase 2: Add 800 mL of 2.25% SLS in 0.01 M HCl. 1000 (phase 1): 1800 (phase 2) Phase 1: No Sampling. Phase 2: 5, 10, 20, 30, 45, 60 and 90 06/30/2011
Etravirine (25 and 100 mg) Tablet  II (Paddle)  50 1.0 % Sodium lauryl sulfate (SLS) in 0.01 M HCl in two phases: Phase 1: 500 mL of degassed 0.01 M HCl for 10 minutes. Phase 2: Add 400 mL of 2.25% SLS in 0.01 M HCl. 500 (phase 1): 900 (phase 2) Phase 1: No Sampling. Phase 2: 5, 10, 20, 30, 45, 60 and 90 08/14/2014
Everolimus Tablet Develop a dissolution method 09/15/2023
Exemestane Tablet Develop a dissolution method 09/15/2023
Exenatide Synthetic (2 mg) For Suspension, Extended Release Develop a method to characterize in vitro release  07/07/2022
Exenatide Synthetic (2 mg/0.85 mL) Suspension, Extended Release Develop a method to characterize in vitro release  07/07/2022
Ezetimibe Tablet II (Paddle) 50 0.45% SLS in 0.05 M Acetate Buffer, pH 4.5 500 10, 20, 30 and 45 01/14/2008
Ezetimibe/Simvastatin Tablet II (Paddle) 50 0.01 M Sodium Phosphate, pH 7.0/0.5% SDS 900 5, 10, 20 and 30 01/03/2007
Ezogabine Tablet  II (Paddle) 75 0.01 N HCl 1000 5, 10, 15, 20 and 30 08/15/2013
Famciclovir Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Famotidine Tablet Refer to USP 02/09/2023
Famotidine Tablet (Orally Disintegrating) II (Paddle) 50 0.1 M Phosphate Buffer, pH 4.5  900 2, 5, 10, 15 and 20  10/06/2008
Famotidine Tablet (Chewable) II (Paddle) 50 0.1 M Phosphate Buffer, pH 4.5 900 10, 20, 30, 45 and 60 01/29/2004
Famotidine Suspension II (Paddle) 25 and 50 0.1 M Phosphate buffer, pH 4.5 900 10, 15, 30 and 45 11/25/2008
Famotidine/Calcium Carbonate/Magnesium Hydroxide Tablet (Chewable) Develop a dissolution method  12/15/2009
Famotidine/Ibuprofen Tablet  II (Paddle) 50 0.05 M Phosphate Buffer, pH 7.2 900 5, 10, 15, 20, 30 and 45 08/15/2013
Febuxostat Tablet  II (Paddle) 75 0.05 M Phosphate Buffer, pH 6.0 900  5, 10, 15, 20 and 30 08/15/2013
Fedratinib HCl Capsule I (Basket) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 08/19/2021
Felbamate Tablet Develop a dissolution method 01/03/2024
Felbamate Suspension Develop a dissolution method 09/15/2023
Felodipine Tablet (Extended Release) Develop a dissolution method 01/03/2024
Fenofibrate Capsule II (Paddle) 75 Phosphate Buffer w/ 2% Tween 80 and 0.1% pancreatin, pH 6.8 900 15, 30, 45, 60, 90 and 120 02/19/2008
Fenofibrate Capsule (Micronized) Develop a dissolution method 09/15/2023
Fenofibrate (40 mg and 120 mg) Tablet  Develop a dissolution method 09/15/2023
Fenofibrate (48 mg and 145 mg) Tablet  Develop a dissolution method 09/15/2023
Fenofibrate (54 mg and 160 mg) Tablet  Develop a dissolution method 09/15/2023
Fenofibric Acid Tablet II (Paddle) 75 Phosphate buffer, pH 6.8 900 5, 15, 30, 45 and 60 08/05/2010
Fenoprofen Calcium Capsule Refer to USP 11/25/2008
Fentanyl Transdermal  VII (Reciprocating holder)- cylinder. 30 cycles per minute. amplitude of about 2m. Equimolar mixture of 0.005 M phosphoric acid solution, and 0.005 M sodium phosphate, monobasic monohydrate (pH ~ 2.6). at 32° C. Change the test samples into fresh pre-equilibrated release medium at the time points indicated. Remove the protective liner and place the film onto a piece of nylon netting with adhesive facing the net. Secure the netting and transdermal system using nylon tie wraps at the top and bottom of the cylinder on the holder. The adhesive side faces towards the media. 250 mL for the 75 and 100 mcg/hr, 200 mL for the 50 mcg/hr and 150 mL for the 25 and 12.5 mcg/hr dosage strength. 0.5, 1, 2, 4 and 24 hours 06/09/2011
Fentanyl Citrate Tablet (Sublingual) II (Paddle) 50 Phosphate Buffer, pH 6.8  500 1, 3, 5, 7, 10, 15 and 20 08/15/2013
Fentanyl Citrate Lozenges II (Paddle) 175 0.1 M Phosphate Buffer, pH 4.5 500 5, 10, 20, 30 and 40 05/20/2009
Fentanyl Citrate (0.1 mg and 0.4 mg) Tablet (Buccal) II (Paddle) small volume dissolution apparatus 100 Phosphate Buffered Saline solution, pH 7.0 100 3, 5, 7.5, 10, 15 and 20 11/20/2009
Fentanyl Citrate (0.2 mg, 0.3 mg, 0.6 mg and 0.8 mg) Tablet (Buccal) II (Paddle) small volume dissolution apparatus 100 Phosphate Buffered Saline solution, pH 7.0 200 3, 5, 7.5, 10, 15 and 20 11/20/2009
Fentanyl Citrate (0.2 mg, 0.4 mg, 0.6 mg and 0.8 mg) Film (Buccal) I (Basket) 100 mL dissolution vessel 100 25-mM Phosphate Buffer, pH 6.4 60 5, 10, 15, 20, 30 and 45 12/15/2009
Fentanyl Citrate (1.2 mg) Film (Buccal) I (Basket) 100 mL dissolution vessel 100 25-mM Phosphate Buffer, pH 6.4 100 5, 10, 15, 20, 30 and 45 12/15/2009
Ferric Citrate Tablet II (Paddle) 100 EDTA media ( 2.0 grams of EDTA Na2 2H2O to 1000 mL of purified water) 900 10, 20, 30, 45 and 60 08/27/2015
Ferric Maltol Capsule II (Paddle with sinker) 75 Tier 1: KCl/HCl Buffer, pH 1.2; Tier 2: KCl/HCl Buffer pH 1.2, with pepsin 1000 5, 10, 20, 30 and 45 01/30/2020
Ferrous Fumarate Tablet  Refer to USP 03/17/2016
Fesoterodine Fumarate Tablet (Extended Release)   II (Paddle) with sinker  75 Phosphate Buffer, pH 6.8  900 1, 2, 4, 6, 8, 10, 12, 16 and 20 hours 08/15/2013
Fexinidazole Tablet II (Paddle) 75 0.1 N HCl with 3% w/v SLS 2000 10, 20, 30, 40, 50 and 60 05/18/2023
Fexofenadine HCl Tablet II (Paddle) 50 0.001 N HCl 900 5, 10, 20, 30 and 45 02/19/2004
Fexofenadine HCl Capsule Develop a dissolution method 09/15/2023
Fexofenadine HCl Suspension II (Paddle) 50 0.001 N HCl 900 10, 20, 30 and 45 11/25/2008
Fexofenadine HCl Tablet (Orally Disintegrating) II (Paddle) 50 0.001 N HCl 500 5, 10, 15, 30 and 45 09/03/2008
Fexofenadine HCl/Pseudoephedrine HCl Tablet (Extended Release) Refer to USP 04/02/2009
Fidaxomicin For Oral Suspension Develop a dissolution method 09/15/2023
Fidaxomicin Tablet  Develop a dissolution method 09/15/2023
Finafloxacin Otic Suspension Develop a method to characterize in vitro release 03/17/2016
Finasteride Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Finasteride; Tadalafil Capsule Develop a dissolution method 02/05/2024
Finerenone Tablet II (Paddle) 75 Acetate Buffer, pH 4.5 (for 10 mg strength) and Acetate Buffer, pH 4.5 with 0.1% polysorbate 20 (for 20 mg strength) 900 5, 10, 15, 20 and 30 02/09/2023
Fingolimod Capsule I (Basket)  100 0.1 N HCl with 0.2% SDS (sodium dodecyl sulfate) 500 5, 10, 15, 20 and 30 08/15/2013
Fingolimod Lauryl Sulfate Tablet, Orally Disintegrating II (Paddle) with sinker 50 0.1 N HCl with 0.2% sodium dodecyl sulfate (SDS) 500 5, 10, 15, 20, 25, 30 and 45 11/30/2023
Flavoxate HCl Tablet I (Basket) 100 0.1 N HCl 900 5, 10, 20 and 30 01/29/2004
Flecainide Acetate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Flibanserin Tablet  II (Paddle) 50 Mcilvaine Buffer (Citric Acid/Phosphate Buffer), pH 4.0 900 5, 10, 15, 20 and 30 06/30/2016
Fluconazole Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Fluconazole (200 mg/5 mL) Suspension Develop a dissolution method 09/15/2023
Fluconazole (50 mg/5 mL) Suspension Develop a dissolution method 09/15/2023
Flucytosine Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Fludarabine Phosphate Tablet Develop a dissolution method  09/15/2023
Fludrocortisone Acetate Tablet Refer to USP 05/20/2009
Fluoxetine Capsules (Delayed Release) Refer to USP 07/25/2007
Fluoxetine HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Fluoxetine HCl Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Fluoxetine/Olanzapine Capsule II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 08/17/2006
Fluphenazine HCl Tablet Refer to USP 11/02/2017
Flutamide Capsule Develop a dissolution method 01/03/2024
Fluvastatin Sodium Tablet (Extended Release) Develop a dissolution method 09/15/2023
Fluvastatin Sodium Capsule Develop a dissolution method 01/03/2024
Fluvoxamine Maleate Capsule (Extended Release) II (Paddle) 50 Phosphate Buffer, pH 6.8 900 1, 2, 4, 6, 8 and 12 hours 01/15/2010
Fluvoxamine Maleate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Fosamprenavir Calcium Tablet II (Paddle) 75 250 mM Sodium Acetate/Acetic acid buffer pH 3.5 900 10, 20, 30 and 45 12/16/2005
Fosamprenavir Calcium Oral Suspension II (Paddle) 25 10 mM HCl 900 5, 10,15 and 20 12/03/2007
Fosfomycin Tromethamine For Suspension Develop a dissolution method 07/20/2017
Fosinopril Sodium Tablet Develop a dissolution method 09/15/2023
Fosinopril Sodium/Hydrochlorothiazide Tablet Refer to USP 08/11/2008
Fostemsavir Tromethamine Tablet (Extended Release I (Basket) 100 0.05 M Phosphate Buffer, pH 6.8 buffer, pH 6.8 1000 1, 2, 3, 5, 7, 10, 12, 16, 20 and 24 hours 08/19/2021
Frovatriptan succinate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Furosemide Tablet Refer to USP  08/05/2010
Futibatinib Tablet II (Paddle) 50 50 mM phosphate dihydrogen phosphate buffer, pH 6.8 with 0.5% Tween 80 900 5, 10, 15, 30, 45, 60 and 75 11/30/2023
Gabapentin Tablet I (Basket) 100 Modified simulated gastric fluid (SGF) 900 1, 2, 4, 6, 8, 10, 12, 14 and 16 hours 11/30/2023
Gabapentin Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Gabapentin Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Gabapentin Enacarbil Tablet (Extended Release) II (Paddle) 50 10 mM Phosphate buffer at pH 7.4 with 1.0 % SLS 500 (for 300 mg); 900 (for 600 mg) 0.5, 1, 2, 4, 6, 8, 12 and 24 hours 01/31/2013
Galantamine HBr Capsule (Extended Release) II (Paddle) 50 50 mM potassium dihydrogen phosphate buffer pH 6.5 900 1, 4, 10 and 12 hours 01/20/2006
Galantamine HBr Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Ganaxolone Suspension II (Paddle) 25 2.8% SDS 900 2.5, 5, 7.5, 10, 15, 20 and 30 11/30/2023
Ganciclovir Capsule Develop a dissolution method 09/15/2023
Gefitinib Tablet Develop a dissolution method 09/15/2023
Gemfibrozil Tablet Refer to USP 07/25/2007
Gemifloxacin Mesylate Tablet II (Paddle) 50 0.01 N HCl 900 10, 20, 30 and 45  01/03/2007
Gilteritinib Fumarate Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 45 08/27/2020
Glimepiride Tablet II (Paddle) 75 Phosphate Buffer, pH 7.8 900 5, 10, 15 and 30 07/23/2004
Glimepiride/Pioglitazone HCl Tablet II (Paddle) 75 For Pioglitazone: pH 2.0, HCl Buffer. For Glimepiride: pH 6.8, Sodium Phosphate Buffer with 0.2% sodium dodecyl sulfate 900 For Pioglitazone: 10, 15, 20, 30 and 45; For Glimepiride: 10, 15, 20 and 30 04/02/2009
Glimepiride/Rosiglitazone Maleate Tablet II (Paddle) 75 0.01 M HCl with 0.5% Sodium Dodecyl Sulfate 900 5, 10, 15, 30, 45 and 60 01/03/2007
Glipizide Tablet (Extended Release) II (Paddle) 50 Simulated Intestinal Fluid without pancreatin, pH 7.5 900 1, 2, 4, 8, 16 hours and until at least 80% dissolved 04/10/2008
Glipizide Tablet Refer to USP  08/05/2010
Glipizide/Metformin HCL Tablet Refer to USP 12/18/2008
Glyburide (Micronized) Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 7.5 900 10, 20, 30, 45 and 60 02/02/2004
Glyburide (Non-micronized) Tablet II (Paddle) 75 0.05 M Borate Buffer, pH 9.5 500 10, 20, 30, 45 and 60 02/02/2004
Glyburide/Metformin HCl Tablet Refer to USP 01/14/2008
Glycopyrrolate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Goserelin Acetate Implant Prior to sampling, the jar is removed from incubation and mechanically swirled with digital orbital shaker Swirl orbit of 50 mm at 205 rpm for 6 seconds Each implant should be incubated in 50 mL of phosphate buffered saline, pH 7.4, at 39°C (warmed overnight before the implants are added), in a 120-mL Wheaton jar. 50 3, 14, 35, 56 and 84 days (10.8 mg strength); 7, 14, 17, 21 and 28 days (3.6 mg strength) 11/04/2008
Granisetron Injectable (Extended Release) Develop a method to characterize in vitro release 12/22/2016
Granisetron Film, Transdermal (Extended Release)   VI (Cylinder) 50 80 microL /L phosphoric acid (85%) at 32 ± 0.5°C 1000 2, 6, 12, 24, 36, 48, 60, 72 and 96 hours 03/03/2011
Granisetron HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Griseofulvin Oral Suspension Develop a dissolution method 09/15/2023
Griseofulvin (Microcrystalline) Oral Suspension Develop a dissolution method 09/15/2023
Griseofulvin (Microcrystalline) Tablet Develop a dissolution method 01/03/2024
Griseofulvin (Ultramicrocrystalline) Tablet Develop a dissolution method 01/03/2024
Guaifenesin Tablet (Extended Release) I (Basket) 75 0.1 N HCl 900 1, 2, 4, 6 and 12 hours 01/03/2007
Guaifenesin/Pseudoephedrine Hydrochloride Tablet (Extended Release) I (Basket) 50 0.01 N HCl 900 1, 2, 6, and 12 hours 11/25/2008
Guanfacine Tablet (Extended Release)  II (Paddle)  75 HCl Buffer, pH 2.2 900 1, 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours 07/01/2010
Guanfacine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 500 08/19/2021
Haloperidol Tablet Refer to USP 11/25/2008
Homatropine Methylbromide/Hydrocodone Bitartrate Tablet Develop a dissolution method 01/03/2024
Hydralazine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Hydrochlorothiazide Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Hydrochlorothiazide Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Hydrochlorothiazide/Irbesartan Tablet II (Paddle) 50 0.1 N HCl 1000 10, 20, 30 and 45 09/24/2008
Hydrochlorothiazide/Lisinopril Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 02/03/2004
Hydrochlorothiazide/Losartan Potassium Tablet Develop a dissolution method 09/15/2023
Hydrochlorothiazide/Metoprolol Succinate Tablet (Extended Release)  II (Paddle) Hydrochlorothiazide: 100; Metoprolol succinate: 75 Hydrochlorothiazide: 0.1N HCl; Metoprolol succinate: Phosphate Buffer, pH 6.8 Hydrochlorothiazide: 500; Metoprolol succinate: 500 Hydrochlorothiazide: 10, 15, 20, 30, and 45 minutes; Metoprolol succinate: 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 10/31/2013
Hydrochlorothiazide/Metoprolol Tartrate Tablet  Refer to USP  01/05/2012
Hydrochlorothiazide/Moexipril HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/10/2004
Hydrochlorothiazide/Olmesartan Medoxomil Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.8 900 5, 10, 15, 20, 30, 45 and 60 07/09/2007
Hydrochlorothiazide/Quinapril HCl Tablet Develop a dissolution method 09/15/2023
Hydrochlorothiazide/Spironolactone Tablet Refer to USP 08/27/2009
Hydrochlorothiazide/Telmisartan Tablet  Refer to USP  06/30/2016
Hydrochlorothiazide/Triamterene Tablet Refer to USP 07/31/2013
Hydrochlorothiazide/Valsartan Tablet  Refer to USP  07/28/2016
Hydrochlorothizide/Triamterene Capsule Refer to USP 10/06/2008
Hydrocodone Bitartrate Capsule (Extended Release) I (Basket) 100 0.05 M Phosphate Buffer, pH 6.8 500 1, 2, 4, 6, 8, 10 and 12 hours 05/28/2015
Hydrocodone Bitartrate Tablet (Extended Release) I (Basket-10 mesh)  100 Simulated gastric fluid (SGF) without enzyme (pH 1.2) 900 1, 2, 4, 8, 12, 16, 20 and 24 hours 04/14/2016
Hydrocodone Bitartrate/Ibuprofen Tablet II (Paddle) 50 Phosphate Buffer, pH 7.2 900 5, 10, 15 and 30 02/04/2004
Hydrocortisone Tablet Develop a dissolution method 01/03/2024
Hydromorphone HCl Tablet (Extended Release)  Develop a dissolution method 09/15/2023
Hydromorphone HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Hydroxychloroquine Sulfate Tablet Refer to FDA's Dissolution Guidance, 2018 04/16/2020
Hydroxyurea Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Hydroxyurea Tablet Refer to FDA's Dissolution Guidance, 2018 07/07/2022
Hydroxyzine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Hydroxyzine Pamoate Capsule Refer to USP 04/02/2009
Hydroxyzine Pamoate Suspension Develop a dissolution method  04/02/2009
Ibandronate Sodium Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Ibrexafungerp Citrate Tablet II (Paddle) 50 0.1N HCl 900 10, 15, 20, 30 and 45 02/09/2023
Ibrutinib Capsule II (Paddle) 75 3.0% w/v Polysorbate 20 in 50 mM Phosphate Buffer, pH 6.8 900 5, 10, 20, 30 and 45 06/25/2015
Ibrutinib (140 and 280 mg) Tablet II (Paddle) 75 3.0% w/v Polysorbate 20 in 50 mM Phosphate Buffer, pH 6.8 900 10, 20, 30, 45 and 60 04/02/2020
Ibrutinib (420 and 560 mg) Tablet II (Paddle) 75 6.0% w/v Polysorbate 20 in 50 mM Phosphate Buffer, pH 6.8 900 10, 20, 30, 45 and 60 04/02/2020
Ibuprofen Tablet (Chewable) II (Paddle) 50 0.05 M Phosphate Buffer, pH 7.2 900 10, 20, 30 and 45 02/04/2004
Ibuprofen Capsule (Soft-Gelatin/Liquid Fill)  I (Basket)  150 50mM Phosphate Buffer, pH 7.2  900 5, 10, 20, 30 and 45 05/09/2013
Ibuprofen Suspension Refer to USP 11/04/2008
Ibuprofen Suspension/Drop II (Paddle) 50 Phosphate Buffer, pH 7.2 900 5, 10, 15 and 20 11/04/2008
Ibuprofen Tablet Refer to USP 07/25/2007
Ibuprofen Potassium Capsule (Soft-Gelatin/Liquid Fill) I (Basket) 150 Phosphate Buffer, pH 7.2 900 5, 10, 20 and 30 02/04/2004
Ibuprofen Sodium Capsule I (Basket) 150 Phosphate Buffer, pH 7.2 900 5, 10, 15, 20 and 30 06/25/2015
Ibuprofen/Diphenhydramine Capsule I (Basket) 100 Phosphate Buffer (200 mM), pH7.2 900 10, 20, 30 and 45  01/03/2007
Ibuprofen/Oxycodone HCl Tablet I (Basket) 100 Phosphate buffer, pH 7.2 500 10, 20, 30 and 45 04/09/2007
Ibuprofen/Phenylephrine HCl Tablet  II (Paddle) 50 50 mM Potassium Phosphate Buffer, pH 6.5, (degassed) 900 10, 15, 20, 30 and 45  01/05/2012
Ibuprofen/Pseudoephedrine HCl Capsule I (Basket) 150 Tier 1: 0.05 M phosphate buffer, pH 7.2 Tier 2: 0.05 M phosphate buffer, pH 7.2 with NMT 1750 USP protease units/L of 1 X USP pancreatin 900 10, 20, 30 and 45 03/04/2006
Ibuprofen/Pseudoephedrine HCl Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 7.2 900 5, 10, 15 and 30 02/04/2004
Icosapent Ethyl Capsule Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate pharmacopoeial apparatus, for comparative evaluation by the Agency. 08/15/2013
Idelalisib Tablet II (Paddle) 75 0.01 N HCl 750 5, 10, 15, 20 and 30 08/27/2015
Iloperidone Tablet II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 30, 45 and 60 08/05/2010
Imatinib Mesylate Tablet  II (Paddle) 50 0.1 N HCl  1000 5, 10, 15, 20 and 30 09/22/2011
Imipramine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Imipramine Pamoate Capsule I (Basket) 100 0.1 N HCl without pepsin and with 0.3% pepsin (addition of pepsin is recommended only when significant slow dissolution is observed) 900 30, 60, 90, 120, 150 and 180 01/14/2008
Indapamide Tablet Refer to USP 04/15/2008
Indinavir Sulfate Capsule II (Paddle) 50 0.1 M Citrate Buffer, pH 3.8 900 10, 15, 20 and 30 02/04/2004
Indomethacin Rectal Suppository Refer to USP 08/26/2021
Indomethacin Capsule (Extended Release) Refer to USP 07/25/2007
Indomethacin (40 mg and 20 mg) Capsule I (Basket) 100 10 mM citric acid buffer, pH 5.75 750 5, 10, 15, 20 and 30 05/28/2015
Indomethacin (50 and 25 mg) Capsule Refer to USP 05/28/2015
Infigratinib Phosphate Capsule I (Basket) 100 0.01 N HCl 900 15, 30, 45 and 60 05/18/2023
Irbesartan Tablet Refer to USP 08/11/2008
Isavuconazonium Sulfate Capsule  II (Paddle) with sinker 75 Diluted McIlvaine Buffer [12.5 mM disodium hydrogen phosphate solution +6.25 mM citric acid solution ] + 0.5 % Sodium Lauryl sulfate (SLS) 900 10, 20, 30, 45, 60, 75 and 90 03/17/2016
Isocarboxazid Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 02/04/2004
Isoniazid Tablet Refer to USP 04/15/2008
Isosorbide Dinitrate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Isosorbide Dinitrate Capsule (Extended Release) Refer to USP 06/25/2015
Isosorbide Dinitrate Tablet (Extended Release) Develop a dissolution method 01/03/2024
Isosorbide Dinitrate/Hydralazine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 08/19/2021
Isosorbide Mononitrate Tablet Develop a dissolution method 09/15/2023
Isosorbide Mononitrate Tablet (Extended Release) Develop a dissolution method 01/03/2024
Isotretinoin Capsule Refer to USP 04/22/2021
Isradipine Capsule Develop a dissolution method 09/15/2023
Isradipine Tablet (Extended Release) Develop a dissolution method 09/15/2023
Istradefylline Tablet Develop a dissolution method 09/15/2023
Itraconazole Capsule II (Paddle) 100 SGF without Enzyme 900 10, 20, 30, 45, 60 and 90 02/04/2004
Itraconazole Tablet  II (Paddle) 75 0.1 N HCl 900 5, 15, 30, 45, 60, 75 and 90 08/15/2013
Ivabradine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Ivacaftor Tablet II (Paddle) with sinker 65 50 mM Sodium Phosphate Buffer with 0.7% Sodium Dodecyl Sulfate (SDS), pH 6.8 900 5, 10, 15, 20 and 30 06/25/2015
Ivacaftor/lumacaftor Tablet Lumacaftor: II (Paddle); Ivacaftor: II (Paddle) Lumacaftor:65; Ivacaftor: 65 Lumacaftor: 0.5% (w/v) CTAB in 50 mM Sodium Acetate Trihydrate buffer (pH 4.5); Ivacaftor: 0.4% (w/v) SLS in 50 mM Sodium Phosphate buffer (pH 6.8) Lumacaftor: 900; Ivacaftor: 900 5, 10, 15, 20 and 30 03/17/2016
Ivacaftor/Tezacaftor [FDC: IVA+ TEZ]; Ivacaftor [IVA] Tablet/Tablet (Copackage) II (Paddle) with option to use a sinker FDC: IVA: 65/TEZ:75; IVA: 65 FDC: IVA: 50 mM Sodium Phosphate Buffer with 0.4% Sodium Dodecyl Sulfate (SDS), pH 6.8/TEZ: 0.2 SDS% in 0.1 N HCl; IVA: 50 mM Sodium Phosphate Buffer with 0.7% SDS, pH 6.8; FDC: IVA: 900/ TEZ: 900; IVA: 900 5, 10, 15, 20, 30 and 45 03/07/2019
Ivermectin Tablet II (Paddle) 50 0.5% SDS in 0.01 M Monobasic Sodium Phosphate, pH 7.0 900 10, 20, 30, 45 and 60 02/04/2004
Ivosidenib Tablet II (Paddle) 50 50 mM Phosphate Buffer pH, 6.8 with 0.6% sodium dodecyl sulfate (SDS), 900 10, 15, 20, 30 and 45 08/27/2020
Ixazomib Citrate Capsule   I (Basket)   100 0.1 N HCl 500 5, 10, 15, 20 and 30 10/20/2016
Ketoconazole Tablet I (Basket) 100 Simulated gastric fluid w/o pepsin 800 15, 30, 45, 60 and 90 01/03/2007
Ketoprofen Tablet II (Paddle) 50 SIF Buffer without enzyme, pH 7.4 900 10, 20, 30, 45 and 60 02/05/2004
Ketoprofen Capsule II (Paddle with sinker) 50 0.05M Potassium Phosphate Buffer, pH 7.4 1000 10, 20, and 30 02/09/2023
Ketorolac Tromethamine Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Labetalol HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Lacosamide Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Lamivudine Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Lamivudine 150 mg/Zidovudine 300mg Tablets and Abacavir Sulfate 300 mg Tablets-co-packaged Tablet II (Paddle) 75 0.1 N HCl 900 5, 10, 15, 20, 30 and 40 01/03/2007
Lamivudine/Raltegravir Ka Tablet Develop a dissolution method 09/15/2023
Lamivudine/Stavudine/Nevirapine Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, 45 and 60 01/03/2007
Lamivudine/Zidovudine Tablet Refer to USP 11/02/2017
Lamivudine/Zidovudine + Efavirenz Tablet (Copackage) II (Paddle) Lamivudine and Zidovudine: 75 Lamivudine and Zidovudine: 0.1 N HCl Efavirenz: Develop a dissolution method Lamivudine and Zidovudine: 1000 10, 20, 30, and 45  09/15/2023
Lamivudine/Zidovudine + Nevirapine Tablet (Copackage) II (Paddle) 50 Lamivudine and Zidovudine: Develop a dissolution method Nevirapine: 0.06 M HCl (pH 1.2) 900 10, 15, 30, 45 and 60 09/15/2023
Lamivudine/Zidovudine/ Nevirapine Tablet II (Paddle) 50 0.01 N HCl 900 10, 15, 30, 45 and 60 01/03/2007
Lamotrigine Tablet (Extended Release)  Refer to USP 02/18/2016
Lamotrigine Tablet, For Suspension Refer to USP 02/09/2023
Lamotrigine Tablet (Regular) II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 03/04/2006
Lamotrigine Tablet (Chewable dispersible) II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 01/14/2008
Lansoprazole Capsule (Delayed Release) Refer to USP 11/04/2008
Lansoprazole Tablet (Delayed Release, Orally Disintegrating) II (Paddle) 75 Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 with 5 mM Sodium Dodecyl Sulfate 500 (Acid), 900 (Buffer) 60 (Acid), 10, 20, 30 and 45 (Buffer) 11/04/2008
Lanthanum Carbonate Chewable Tablet Reciprocating Cylinder (Apparatus 3 modified) 10 dpm (dip rate per minute) 0.25 N HCl 900 (modified from the standard apparatus 3 vessel to achieve sink condition) 10, 20, 30 and 45 01/03/2007
Lapatinib Ditosylate Tablet II (Paddle) 55 2% Polysorbate 80 in 0.1 N HCl 900 10, 15, 30 and 45 10/30/2009
Lasmiditan Succinate Tablet Refer to FDA's Dissolution Guidance, 2018 05/12/2022
Ledipasvir/Sofosbuvir Pellets II (Paddle) 75 1.0% polysorbate 80 in 25 mM Potassium Phosphate Buffer, with 0.005 mg/mL Butylated Hydroxytoluene (BHT), pH 5.5 900 5, 10, 15, 20, 30, 45 and 60 08/19/2021
Ledipasvir/Sofosbuvir Tablet II (Paddle) 75 1.5% Polysorbate 80 in 10 mM Potassium Phosphate Buffer with 0.0075 mg/mL Butylated Hydroxytoluene (BHT), pH 6.0 900 5, 10, 15, 20, 30, 45 and 60 08/27/2015
Lefamulin Acetate Tablet II (Paddle) 50 0.1 N HCl 1000 10, 20, 30, 45, 60, 75, and 90 04/22/2021
Leflunomide Tablet Develop a dissolution method 09/15/2023
Leflunomide (100 mg) Tablet Develop a dissolution method 09/15/2023
Lemborexant Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 05/12/2022
Lenacapavir Sodium Tablet II (Paddle) with sinkers 75 30 mM potassium phosphate, pH 6.0 with 2.0% Cremophor EL 900 10, 15, 20, 25, 30, 45 and 60 02/05/2024
Lenalidomide Capsule II (Paddle) 50 0.01 N HCl 900 10, 15, 20, 30 and 45 04/15/2008
Lenvatinib Mesylate Capsule  II (Paddle)  50 0.1 N HCl 900 5, 10, 15, 20 and 30 03/17/2016
Lesinurad Tablet  II (Paddle) 75 pH 4.5 sodium acetate buffer with 1% SLS 900 10, 20, 30 and 45 03/17/2016
Letermovir Tablet II (Paddle) 75 25 mM Na Acetate Buffer, pH 4.5 with 0.6% Tween-80 900 10, 15, 20, 30, 45 and 60 02/08/2018
Letrozole Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Letrozole (LET); Ribociclib Succinate (RIB) Tablet/Tablet (Copackage) II (Paddle) RIB: 50; LET: 75 RIB: 0.01 N HCl; LET: 0.1 N HCl RIB: 900; LET: 900 5, 10, 15, 20, 30 and 45 03/07/2019
Leucovorin Calcium Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Leuprolide Acetate Implant Develop a method to characterize in vitro releas 05/12/2022
Leuprolide Acetate Injectable (Extended Release) Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 01/15/2010
Leuprolide Mesylate Emulsion Develop a method to characterize in vitro release 10/06/2023
Levetiracetam Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Levetiracetam Tablet, for Suspension II (Paddle) 50 Phosphate Buffer, pH 6.8 (degas) 900 2.5, 5, 10, 15 and 20 03/02/2017
Levetiracetam Tablet (Extended Release) I (Basket) 100 0.05 M Phosphate Buffer, pH 6.0 900 1, 2, 4, 6, 8 and 12 hours 04/02/2009
Levocarnitine Tablet Develop a dissolution method 01/03/2024
Levocetirizine Dihydrochloride Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Levofloxacin Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Levomilnacipran HCl Capsule (Extended Release) Develop a dissolution method 09/15/2023
Levonorgestrel Tablet II (Paddle) 75 0.1 N HCl with 0.1% SLS 1000 10, 20, 30, 45, 60 and 90 02/05/2004
Levonorgestrel Intrauterine Device Develop a method to characterize in vitro release   02/14/2014
Levorphanol Tartrate Tablet Refer to FDA's Dissolution Guidance, 2018 04/22/2021
Levothyroxine Sodium Tablet Refer to USP 07/25/2007
Lidocaine Topical Patch Paddle over Disk (Apparatus 5) 50 Acetic acid/sodium acetate buffer, pH 4.0 at 32ºC 500 10, 20, 30, 60, 120 and 180 01/03/2007
Linaclotide Capsule I (Basket) 50 50 mM Phosphate Buffer, pH 4.5 500 5, 10, 15, 20 and 30 12/24/2015
Linagliptin Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Linagliptin/Metformin HCl Tablet II (Paddle)  50 0.1 N HCl  900  5, 10, 15, 20, 30 and 45 05/15/2014
Linagliptin/Metformin HCl Tablet (Extended Release)  I (Basket) 100 Simulated Gastric Fluid (SGF) without enzyme (pH 1.2) (degassed) 900 Linagliptin 10, 15, 20, 30 and 45 minutes; Metformin: 1, 2, 4, 6, 8 and 12 hours 07/28/2016
Linezolid Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Linezolid Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.8 900 10, 20, 30 and 45 01/14/2008
Liothyronine Sodium Tablet Refer to USP 06/18/2007
Lisdexamfetamine Dimesylate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Lisinopril Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Lithium Carbonate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Lithium Carbonate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Lithium Carbonate Tablet (Extended Release) Refer to USP 01/14/2008
Lomefloxacin HCl Tablet II (Paddle) 50 0.01 N HCl 900 10, 20, 30 and 45 02/05/2004
Lomitapide Mesylate  Capsule II (Paddle) 50 0.001 N HCl with 0.1% Polysorbate 80 500 mL (5 mg strength); 1000 mL (10 and 20 mg strength) 5, 10, 20, 30 and 45 06/25/2015
Lomustine Capsule Develop a dissolution method  12/24/2015
Lonafarnib Capsule Develop a dissolution method 09/15/2023
Loperamide HCl Oral Suspension II (Paddle) 25 0.01 N HCl 900 10, 20, 30, 45, 60, 75 and 90 06/25/2015
Loperamide HCl Tablet (Chewable) II (Paddle) 50 0.2 M Acetate Buffer, pH 4.7 500 5, 10, 15, 20 and 30 06/25/2015
Loperamide HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Loperamide HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Loperamide HCl/Simethicone Tablet II (Paddle) 75 0.1N HCl 500 10, 15, 20, 30 and 45 08/27/2015
Loperamide HCl/Simethicone Tablet (Chewable) II (Paddle) 50 0.2 M Acetate Buffer, pH 4.7 500 5, 10, 15, 20 and 30 02/09/2023
Lopinavir/Ritonavir Tablet (Combination) Refer to USP 01/15/2015
Lopinavir/Ritonavir Capsule (Soft-Gelatin) II (Paddle) 50 Tier 1: 0.05 M Polyoxyethylene 10 Lauryl Ether with 10 mM Sodium Phosphate monobasic (pH 6.8); Tier II: same as above with NMT 1750 USP units/L of Pancreatin 900 10, 15, 30 and 45 06/18/2007
Loratadine Tablet (Chewable) II (paddle) 50 0.1 N HCl 500 15, 30, 45 and 60 07/14/2008
Loratadine Tablet (Orally Disintegrating) I (Basket) 50 SGF without enzyme 900 2, 4, 6 and 10 07/14/2008
Loratadine Capsule (Soft-Gelatin)  II (Paddle) with sinker 75 Tier I: 0.1N HCl with 0.1% Tween 20. Tier II: 0.1N HCl with 0.1% Tween 20 with addition of pepsin (as per USP). 900 10, 20, 30, 45 and 60  02/28/2013
Loratadine/Pseudoephedrine Sulfate (10 mg /240 mg) Tablet (Extended Release)  I (Basket) 75 900 mL 0.1 N HCl for one hour, then replace the medium with 900 mL 0.05 M phosphate buffer at pH6.8 containing 0.01% sodium lauryl sulfate. 900 Loratadine:10, 15, 20, 30 and 45; Pseudoephedrine: 1, 2, 4, 8, 12, 16, 18 and 24 hours 08/05/2010
Loratadine/Pseudoephedrine Sulfate (5 mg /120 mg) Tablet (Extended Release)  II (Paddle) 50 900 mL 0.1 N HCl for one hour, then replace with 900 mL 0.05 M phosphate buffer at pH 8.2 containing 0.01% sodium lauryl sulfate 900 Loratadine:15, 20, 30, 45, 60 and 90; Pseudoephedrine: 1, 2, 4, 8, 12 and 16 hours 08/05/2010
Lorazepam Capsule (Extended Release) I (Basket) 100 Acid Stage: 0.1N HCl; Buffer stage: Sodium Phosphate Buffer, pH 7.4 Acid stage: 700; Buffer stage: 1000 Acid stage: 0.5, 1 and 2 hours; Buffer stage: 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours 05/12/2022
Lorazepam Tablet Develop a dissolution method 01/03/2024
Lorcaserin HCl Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Lorcaserin HCl Tablet (Extended Release)   I (Basket)   100 0.1 N HCl (deaerated) 900 1, 2, 4, 5, 8 12, 16 and 20 hours 10/20/2016
Losartan Potassium Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Loteprednol Etabonate Ophthalmic Suspension Develop a method to characterize in vitro release 06/30/2016
Loteprednol Etabonate/Tobramycin Ophthalmic Suspension   Develop a method to characterize in vitro release   01/31/2013
Lovastatin Tablet (Extended Release) II (Paddle) 50 0.5% sodium lauryl sulfate (SLS) / sodium phosphate buffer (0.01M), pH 6.5 900 1, 2, 4, 6, 8, 12, 16 and 20 hours 02/07/2019
Lovastatin/Niacin Tablet (Extended Release) I (Basket) 100 For Niacin: Develop a dissolution method; for Lovastatin: 0.05 M phosphate buffer, pH 7.0 with 0.5% sodium dodecyl sulfate 900 For Lovastatin: 15, 30, 45 and 60 min 09/15/2023
Lubiprostone Capsule (Soft-Gelatin) II (Paddle)  50 0.1 N HCl/1% HCO-40 (Polyoxyl 40 hydrogenated castor oil) 900 15, 30, 45, 60, 90 and 120 08/19/2010
Lurasidone HCl Tablet II (Paddle) 50 McIlvaine buffer, pH 3.8 [(0.025 M Citric acid Solution + 0.05M Na2HPO4 solution (3:2)] Measure the pH and adjust to 3.8, if necessary. Degas before use. 900 5, 10, 15, 20 and 30  01/31/2013
Macitentan Tablet II (Paddle) 75 Phosphate Buffer, pH 6.8 with 0.1% of Cetrimonium bromide (CTAB) 900 10, 15, 20, 30 and 45 05/28/2015
Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate Tablet (Chewable) II (Paddle) 150 0.029 M sodium phosphate buffer w/ 0.5% SDS, pH 7.4 900 15, 30, 45, and 60 02/19/2008
Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate Tablet (Chewable) II (Paddle) 150 pH 7.4 Phosphate Buffer with 0.5% SDS 900 15, 30, 45, 60 and 90 10/06/2008
Magnesium Sulfate/Potassium Chloride/Sodium Sulfate Tablet Develop a dissolution method 09/15/2023
Maraviroc Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Maribavir Tablet II (Paddle) 50 0.1N HCl (deaerated) 900 10, 15, 20, 30 and 45 02/09/2023
Maribavir Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 45 07/07/2023
Mavacamten Capsule II (Paddle) 50 Tier 1: 0.05%(w/v) SDS in 50 mM Sodium Phosphate, pH 6.8; Tier 2: 50 mM sodium phosphate, pH 6.8, containing NMT 2,000 unit/L of pancreatin (850 mL). After 10 minutes, add 50 mL of 50 mM sodium phosphate, pH 6.8, containing 0.9% (w/v) SDS 900 10, 15, 30, 45 and 60 05/18/2023
Mebendazole Tablet (Chewable) II (Paddle) 75 0.1 N HCl containing 1% Sodium Lauryl Sulfate 900 15, 30, 45, 60, 90 and 120 10/06/2008
Mebendazole ( 500 mg) Tablet (Chewable) II (Paddle) 75 1% Sodium Lauryl Sulfate (SLS) in 0.01 N HCl 900 5, 10, 15, 30, 45 and 60 12/22/2016
Mecamylamine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Meclizine HCl Tablet I (Basket) 100 0.01 N HCl 900 10, 20, 30, 45 and 60 08/27/2009
Meclizine HCl Tablet (Chewable) I (Basket) 100 0.01 N HCl  900 10, 20, 30, 45 and 60 04/08/2010
Medroxyprogesterone Acetate Injectable Suspension  Develop a dissolution method 09/15/2023
Medroxyprogesterone Acetate Tablet Develop a dissolution method 01/03/2024
Medroxyprogesterone Acetate (104mg/0.65ml) Injectable Suspension  Develop a method to characterize in vitro release 02/08/2018
Mefenamic Acid Capsule Refer to USP 12/15/2009
Mefloquine HCl Tablet I (Basket) 100 SGF without enzyme 900 10, 20, 30, 45 and 60 02/06/2004
Megestrol Acetate Oral Suspension Develop a dissolution method 01/03/2024
Meloxicam Suspension II (Paddle) 25 Phosphate buffer at pH 7.5 900 5, 10, 15 and 30 01/26/2006
Meloxicam Tablet II (Paddle) 75 Phosphate Buffer, pH 7.5 900 10, 20, 30, 45 and 60 02/20/2004
Meloxicam Capsule I (Basket)  100 Phosphate Buffer, pH 6.1 with 0.1% Sodium Lauryl Sulfate (SLS) 500 mL (for 5 mg); 1000 mL (for 10 mg) 5, 10, 15, 20 and 30 06/30/2016
Melphalan Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Memantine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Memantine HCl Capsule (Extended Release)  I (Basket) 100 pH 1.2 NaCl/HCl Buffer (degas) 900 1, 2, 3, 4, 6, 8, 10 and 12 hours 03/02/2017
Menthol/Methyl Salicylate Topical Patch VI (Cylinder)  50 Neutralized phthalate buffered solution (0.2 M potassium biphthalate) with pH of 5.0 at 32 ± 0.5°C 900 10, 20, 30, 60, 120, 150 and 180  01/31/2013
Meprobamate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Mercaptopurine Oral Suspension II (Paddle) 50 0.1N HCl 900 5, 10, 15, 20 and 30 12/24/2015
Mercaptopurine Tablet II (Paddle) 50 0.1 N HCl 900 20, 30, 45, 60, 90 and 120 02/06/2004
Mesalamine Suppository II (Paddle) with option to use a sinker 75 (for 500 mg) & 125 (for 1000 mg) For 500 mg strength: 0.2 M Phosphate buffer, pH 7.5 at 37 deg. C For 1000 mg strength: 0.2 M Phosphate buffer, pH 7.5 at 40 deg. C 900 30, 60, 90, 120 and 150 01/30/2006
Mesalamine Capsule (Delayed Release) II (Paddle) Phase 1 & 2: 100 rpm; Phase 3: 50 rpm Phase 1: 0.1N HCl (degas); Phase 2: pH 6.0 Buffer (degas); Phase 3: pH 7.2 Buffer Phase 1: 500; Phase 2: 900; Phase 3: 900 Phase 1: 120; Phase 2: 60; Phase 3: 20, 30, 45, 60, 75, 90 and 120 06/30/2016
Mesalamine (1.2 gram) Tablet (Delayed Release) II (Paddle) 100 Acid stage (A): 100 mM HCl Buffer stage (B): Phosphate Buffer, pH 6.4 Buffer stage (C): Phosphate Buffer, pH 7.2 Acid stage (A): 750 mL; Buffer stage (B): 950 mL; Buffer stage (C): 960 mL Acid stage (A): 2 hours; Buffer stage (B): 1 hour; Buffer stage (C): 1, 2, 4, 6 and 8 hours 06/10/2009
Mesalamine (250 mg and 500 mg) Capsule (Extended Release) Refer to USP 06/10/2009
Mesalamine (375 mg) Capsule (Extended Release) I (Basket) 100 Acid Stage: 0.1N HCl Buffer stage: Phosphate Buffer, pH 6.8 Acid stage: 750 mL; Buffer stage: 1000 mL Acid stage: 2 hours; Buffer stage: 0.5, 1, 2, 4, 7 and 9 hours 06/10/2009
Mesalamine (400 mg and 800 mg) Tablet (Delayed Release) Refer to USP 11/05/2010
Mesalamine Enema Rectal Enema II (Paddle) 50 Phosphate Buffer, pH 7.2 900 5, 10, 15, and 30 06/18/2007
Mesna Tablet II (Paddle) 50 0.06 N HCl 500 5, 10, 15, 20 and 30 02/09/2004
Mestranol/Norethindrone Tablet Refer to USP  03/25/2010
Metaxalone Tablet Develop a dissolution method 01/03/2024
Metformin HCl For Suspension (Extended Release) II (Paddle) 100 Phosphate Buffer, pH 6.8 1000 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours 01/30/2020
Metformin HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Metformin HCl Tablet (Extended Release) Refer to USP 12/12/2008
Metformin HCl (MET); Sitagliptin (SIT) Tablet (Extended Release) II (Paddle) with sinker 75 Phosphate buffer, pH 6.8 900 MET: 1, 2, 3, 4, 6, 8, 10, and 12 hours; SIT: 10, 20, 30, 45 and 60 07/07/2023
Metformin HCl/Pioglitazone HCl Tablet II (Paddle) 50 pH 2.5 McIlvaine buffer (0.1 M Citric acid adjusted to pH 2.5 with 0.2 M Na2HPO4) 900 10, 20, 30 and 45 01/03/2007
Metformin HCl/Saxagliptin Tablet (Extended Release)  I (Basket) 100 Phosphate Buffer, pH 6.8  1000 Metformin: 1, 2, 3, 4, 6, 8, 10 and 12 hours. Saxagliptin: 5, 10, 15, 20 and 30 minutes 01/26/2012
Metformin HCl/Sitagliptin Phosphate Tablet II (Paddle) 75 0.025 M NaCl 900 10, 15, 20 and 30 10/06/2008
Metformin/Repaglinide Tablet II (Paddle) 50 Citric acid/phosphate buffer, pH 5.0 900 5, 10, 15, 20 and 30 10/30/2009
Methadone HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Methazolamide Tablet II (Paddle) 100 pH 4.5 Acetate Buffer 900 10, 15, 20, 30 and 45 05/28/2015
Methenamine Hippurate Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Methimazole Tablet Refer to USP 01/14/2008
Methocarbamol Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Methotrexate Sodium Tablet Develop a dissolution method 01/03/2024
Methoxsalen Capsule Develop a dissolution method 01/03/2024
Methscopolamine Bromide Tablet Refer to USP 02/15/2018
Methylergonovine Maleate Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Methylnaltrexone Bromide Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Methylphenidate Tablet (Extended Release, Orally Disintegrating ) II (Paddle) 75 Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 Acid Stage: 900 mL; Buffer Stage: 1000 mL Acid Stage: 15, 30, 60, 120 minutes; Buffer Stage: 1, 2, 3, 4, 6 and 8 hours 11/16/2017
Methylphenidate Tablet (Extended Release)  Develop a dissolution method 01/03/2024
Methylphenidate Capsule (Extended Release) Develop a dissolution method 09/15/2023
Methylphenidate Transdermal Patch VI (Cylinder) 50 0.01 N HCl at 32ºC  900 0.5, 1.5, 3, 4 hours and until at least 80% released 04/15/2008
Methylphenidate (BX) Capsule (Extended Release) I (Basket) 75 0-2 hrs:0.01 N HCl. 2-10 hrs: Phosphate Buffer, pH 6.8. 0-2 hrs: 500. 2-10 hrs:500 0.5, 1, 3, 6, 8 and 10 hours 07/25/2007
Methylphenidate HCl Tablet (Chewable)  Develop a dissolution method 09/15/2023
Methylphenidate HCl Tablet (Extended Release, Chewable)  II (Paddle) 75 0.4M KH2PO4 solution (degas) 900 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours 03/17/2016
Methylphenidate HCl Powder for Suspension (Extended Release)   II (Paddle)  75 0.4 M Phosphate Buffer, pH 4.5 900 0.25, 0.5, 1, 2, 3, 4, 6 and 8 hours 06/02/2016
Methylphenidate HCl Capsule (Extended Release)  I (Basket)   100 Acid Stage:(First 2 hours) 0.01 N HCl; Buffer Stage (2-10 hours): Phosphate Buffer, pH 6.0  Acid: 500 mL; Buffer: 500 mL  0.5, 1, 2, 4, 6, and 10 hours  10/20/2016
Methylphenidate HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Methylphenidate HCl (25 mg, 35 mg, 45 mg, 55 mg, 70 mg and 85 mg) Capsule (Extended Release)  II (Paddle) with sinker 75 Acid Stage:(0-6 hours) Simulated Gastric Fluid [SGF, pH 1.2] without enzyme; Buffer Stage (after six hours in acid stage): Phosphate Buffer, pH 7.4  Acid Stage: 0.5, 1, 2, 4, 6 hours; Buffer Stage: 1, 2, 4, 6, 8 and 10 hours 04/02/2020
Methylprednisolone Tablet Develop a dissolution method 01/03/2024
Methylprednisolone Acetate Injectable Suspension  IV (Flow-Through Cell-Open system) 0.55 % SDS 15, 30, 45, 60, 90 and 120 10/08/2009
Methyltestosterone Capsule Develop a dissolution method 01/03/2024
Methyltestosterone Tablet Develop a dissolution method 09/15/2023
Metoclopramide HCl Tablet (Orally Disintegrating) Develop a dissolution method 09/15/2023
Metoclopramide HCl Tablet Develop a dissolution method 01/03/2024
Metolazone Tablet Refer to USP 04/02/2020
Metoprolol Succinate Tablet (Extended Release) Refer to USP 07/25/2007
Metoprolol Tartrate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Metronidazole Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Metronidazole Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Metyrosine Capsule Refer to USP 02/15/2018
Mexiletine HCl Capsule Refer to FDA's Dissolution Guidance, 2018 04/22/2021
Miconazole Tablet (Buccal) I (Basket) 60 0.5% SDS (Sodium dodecylsulfate) in water-pH adjusted to 6.5 ± 0.5 1000 1, 2, 4, 6, 8, 10 and 12 hours 10/28/2010
Miconazole Nitrate Suppository (Vaginal) I (Basket) 100 0.45% SLS in water 900 15, 30, 45 and 60 10/08/2009
Midodrine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Midostaurin Capsule Develop a dissolution method 09/15/2023
Mifepristone Tablet II (Paddle) 75 0.01 N HCl 900 5, 10, 15, 20 and 30 01/14/2008
Mifepristone [300 mg] Tablet  II (Paddle)  50 pH 1.8 KCl Buffer 900 10, 15, 20, 30 and 45 03/17/2016
Miglitol Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Miglustat Capsule I (Basket) 100 0.1 N HCl 1000 10, 20, 30 and 45  01/03/2007
Milnacipran HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Miltefosine Capsule  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Minocycline HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Minocycline HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Minocycline HCl Capsule (Extended Release)  I (Basket- 10 mesh) 100 0.1 N HCl 900 0.25, 0.5, 1.0, 1.5, 2, 3 and 4 hours 06/02/2016
Minocycline HCl Capsule Develop a dissolution method 01/03/2024
Minocycline HCl ER Tablets I (Basket) 100 0.1 N HCl 900 1, 2, 4, 6 hours and until 80% of drug released 01/14/2008
Minocycline HCl (135 mg and 105 mg) Tablet (Extended Release) I (Basket) 100 pH 2.1 Buffer (Degassed) 900 15, 30, 45, 60, 90, 120, 180 and 210 11/02/2017
Minoxidil Tablet Refer to USP 04/15/2008
Mirabegron Tablet (Extended Release)  I (Basket)  100 Phosphate Buffer, pH 6.8  900 1, 3, 5, 7, 8.5, 10 and 12 hours 05/09/2013
Mirabegron Granules, for Oral Suspension (Extended Release) II (Paddle) 100 Stage 1: USP Phosphate Buffer (0.036 mol), pH 6.8 (0-4 hours); Stage 2: Phosphate Buffer pH 6.8 (0.108 mol), (after 4 hours) Stage 1: 500; Stage 2: 1000 0.25, 0.5, 1, 2, 4, 6, 8 and 10 hours 05/12/2022
Mirtazapine Tablet (Orally Disintegrating (ODT)) II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 03/04/2006
Mirtazapine Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Misoprostol Tablet Develop a dissolution method 09/15/2023
Mitapivat Sulfate Tablet II (Paddle) 70 100 mM sodium phosphate, pH 6.8, with 0.05% w/w sodium dodecyl sulfate (SLS) 900 5, 10, 15, 20 and 30 03/30/2023
Mitotane Tablet Develop a dissolution method 01/03/2024
Mobocertibib Succinate Capsule II (Paddle) 50 0.05 M potassium chloride in 0.085 N hydrochloric acid, pH 1.2 500 10, 15, 20, 30, 45 and 60 10/06/2023
Modafinil Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 02/10/2004
Moexipril HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Molindone HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Monomethyl Fumarate Capsule (Delayed Release) II (Paddle) Stationary Basket over the Paddle 100 Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate buffer, pH 6.8 Acid Stage: 120; Buffer Stage: 15, 30, 45, 60, 90, 120 and 150 08/27/2020
Montelukast Granule Develop a dissolution method 09/15/2023
Montelukast Sodium Tablet Develop a dissolution method 09/15/2023
Montelukast Sodium Tablet (Chewable) Develop a dissolution method 09/15/2023
Morphine Sulfate Tablet (Extended Release)   I (Basket)   100 Simulated Gastric Fluid [SGF] without enzyme 900 0.25, 0.5, 1, 1.5, 2, 4, 6 and 8 hours 10/20/2016
Morphine Sulfate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Morphine Sulfate Capsule (Extended Release) Refer to USP 08/11/2008
Morphine Sulfate (AB) Tablet (Extended Release)  Develop a dissolution method 09/15/2023
Morphine Sulfate (AB2) Capsule (Extended Release)  II (Paddle) 50 Phosphate Buffer, pH 6.8 900 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours 08/14/2014
Morphine Sulfate (BC) Tablet (Extended Release)  Develop a dissolution method 09/15/2023
Morphine Sulfate/Naltrexone HCl Capsule (Extended Release)  II (Paddle) 50 Acid stage: 0.1 N HCl; Buffer stage: 0.05 Phosphate Buffer, pH 7.5   Acid stage: 500; Buffer stage: 500  Morphine Sulfate: Acid stage: 1 hour; Buffer stage: 1, 3, 5, 8 and 10 hours. Naltrexone HCl: Acid stage: 1 hour; Buffer stage: 1, 12, 24, 48, 73 and 96 hours.   01/26/2012
Moxifloxacin Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Mycophenolate Mofetil Suspension II (Paddle) 40 0.1 N HCl 900 5, 10, 20 and 30 02/10/2004
Mycophenolate Mofetil Capsule II (Paddle) 40 0.1 N HCl 900 5, 10, 20 and 30 02/10/2004
Mycophenolate Mofetil Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/10/2004
Mycophenolic acid Tablet (Delayed Release) II (Paddle) 50 Acid Stage: 0.1 N HCl; Buffer Stage: Buffer Solution, pH 6.8 (After initial 120 mins., 250 mL of 0.2 M sodium phosphate solution is added to acid stage medium. The pH of the mixture is adjusted to 6.8 using 0.2 M sodium phosphate, 2 N sodium hydroxide, or concentrated HCl acid solution if necessary.) 750 (Acid), 1000 (Buffer) 120 (Acid), 10, 20, 30, 45 and 60 (Buffer) 12/19/2008
Nabilone Capsule II (Paddle) 50 0.1% Tween 80 solution 1000 15, 30, 45 and 60 07/14/2008
Nabumetone Tablet Develop a dissolution method 01/03/2024
Nadolol Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Naldemedine Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Naloxegol Oxalate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Naltrexone Injectable Suspension  Phosphate buffered saline with 0.02% Tween 20 and 0.02% Sodium azide, pH 7.4 (final osmolality should be 270 ± 20 mOsm), or any other appropriate medium, at 37°C. Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 09/01/2011
Naltrexone HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Naltrexone HCl / Oxycodone HCl Capsule (Extended Release)  Develop a dissolution method 12/22/2016
Naltrexone HCl/Bupropion HCl Tablet (Extended Release) Develop a dissolution method 09/15/2023
Naproxen Suspension Develop a dissolution method 11/16/2017
Naproxen Tablet (Delayed Release)  Refer to USP 12/15/2009
Naproxen Tablet Refer to USP 07/25/2007
Naproxen Sodium Tablet (Extended Release)  II (Paddle) 50 Phosphate Buffer, pH 7.5 900 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 14 hours 04/08/2010
Naproxen Sodium Tablet Refer to USP 10/04/2012
Naproxen Sodium Capsule II (Paddle) 75 Sodium Phosphate Buffer, pH 7.4 ± 0.05 900 10, 15, 20, 30 and 45 05/28/2015
Naproxen Sodium/Diphenhydramine HCl Tablet II (Paddle) 75 0.1M Sodium Phosphate buffer, pH 7.4 (deaerated) 900 5, 10, 15, 20 and 30 06/25/2015
Naproxen Sodium/Diphenhydramine HCl Tablet II (Paddle) 75 0.1M Sodium Phosphate Buffer, pH 7.4 900 5, 10, 15, 20, 30 and 45 05/28/2015
Naproxen Sodium/Sumatriptan Succinate Tablet I (Basket) 75 Phosphate Buffer, pH 6.8 900 10, 15, 20, 30 and 45 07/01/2010
Naproxen/Esomeprazole Magnesium Tablet (Delayed Release)  II (Paddle) with sinkers Naproxen::50 rpm Esomeprazole::75 rpm Naproxen:: Acid Stage: 0.1M HCl; Buffer Stage: 0.05M Phosphate buffer, pH 6.8. Sampling for Acid stage: Transfer the un-dissolved tablet & sinker to the vessel containing the buffer stage medium. Add, 10 mL of 10 M NaOH to each vessel of the remaining acid stage medium. Continue rotation at 100 rpm for 30 minutes, withdraw aliquot and analyze. Esomeprazole (second set of tablets)(without pre-exposure to acid stage):: 0.05M Phosphate buffer, pH 7.4 Naproxen::Acid Stage: 1000; Buffer Stage: 1000; Esomeprazole::900 Naproxen:: Acid stage: 120; Buffer stage: 10, 20, 30, 45, 60, 75 and 90; Esomeprazole::10, 20, 30, 45, 60, 75 and 90 06/06/2013
Naratriptan HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Nateglinide Tablet II (Paddle) 50 0.01 N HCl with 0.5% (w/v) SLS 1000 10, 20, 30 and 45  01/03/2007
Nebivolol HCl Tablet II (Paddle) 50 0.01 N HCl 900 10, 20, 30 and 45 01/15/2010
Nebivolol/Valsartan Tablet I (Basket)   100 67 mM Phosphate Buffer pH 6.8 with 0.5% SDS 900 5, 10, 15, 20 and 30 10/20/2016
Nefazodone HCl Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 01/03/2007
Nelfinavir Mesylate Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20, 30, 45, 60 and 90 01/03/2007
Nelfinavir Mesylate Powder for Suspension II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20, 30, and 45 09/13/2007
Neomycin Sulfate Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.8 900 15, 30, 45 and 60 01/14/2008
Nepafenac Ophthalmic Suspension Develop a method to characterize in vitro release 08/14/2014
Netupitant/Palonosetron HCl Capsule II (Paddle) Netupitant:100; Palonosetron: 75 Netupitant: 0.07M Phosphate buffer pH 6.8 containing 1% sodium SDS ; Palonosetron: 0.01 N HCl Netupitant: 900; Palonosetron: 500 Netupitant: 10, 20, 30, 45, 60 and 75; Palonosetron: 5, 10, 15, 20, 30 and 45 09/03/2015
Nevirapine Tablet (Extended Release) I (Basket) 75 0.04 M Sodium phosphate buffer pH 6.8 containing 2% sodium lauryl sulfate 900 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 20 hours  01/31/2013
Nevirapine Suspension II (Paddle) 25 0.1 N HCl 900 10, 20, 30, 45 and 60 02/11/2004
Nevirapine Tablet Refer to USP 09/13/2007
Niacin Tablet (Extended Release) Develop a dissolution method 09/15/2023
Niacin/Simvastatin Tablet (Extended Release)  Simvastain: I (10 mesh rotating Basket) 100 Niacin: Develop a dissolution method; Simvastatin: 0.5 % SDS in 0.01 M Sodium Phosphate, pH 7.0 900 Simvastatin: 10, 20, 30, 45 and 60 09/15/2023
Nicardipine HCl Capsule II (Paddle) 50 0.033 M Citric Acid Buffer, pH 4.5 900 10, 20, 30 and 45 02/11/2004
Nicardipine HCl Capsule (Extended Release) II (Paddle) 50 0.1 N HCl 1000 0.5 , 2 and 6 hours 07/14/2008
Nicotine Film, Transdermal (Extended Release)   Develop a dissolution method 01/03/2024
Nicotine Polacrilex Chewing Gum Chewing Machine as desribed in European Pharmacopoeia (2.9.25) 60 cycles (chews) per minute Phosphate Buffer, pH 7.4 or or any other appropriate buffer and conditions 20 5, 10, 20 and 30 01/05/2012
Nicotine Polacrilex Lozenge I (Basket) 100 Phosphate Buffer, pH 7.4 900 0.5, 1, 2, 3, 6 and 8 hours 12/23/2010
Nicotine Polacrilex Lozenge (Mini) III (Reciprocating Cylinder) 20 dpm Phosphate buffer pH 7.4 250 15, 30, 45, 60 and 90 03/09/2017
Nifedipine Capsule Refer to USP 03/03/2011
Nifedipine Tablet (Extended Release) Develop a dissolution method 01/03/2024
Nifurtimox Tablet II (Paddle) 100 Acetate Buffer, pH 4.5 with 1.0 % Sodium Dodecyl Sulfate (SDS) (for 30 mg strength) and 1.5 % SDS (for 120 mg strength) 900 10, 20, 30, 60 and 75 07/07/2022
Nifurtimox Tablet II (Paddle) 100 Acetate buffer pH 4.5 with 1% sodium dodecyl sulfate (SDS) for 30 mg strength and 1.5 % SDS for 120 mg strength 900 15, 30, 45, 60, 90 and 120 02/09/2023
Nilotinib HCl Capsule I (Basket) 100 0.1 N HCl 1000 10, 15, 20, 30 and 45 02/05/2024
Nilotinib Hydrochloride Monohydrate Capsule I (Basket) 100 0.1 N HCl 1000 10, 15, 30 and 45 10/30/2009
Nilutamide Tablet Develop a dissolution method  05/20/2009
Nimodipine Capsule Develop a dissolution method 09/15/2023
Nintedanib Esylate Capsule II (Paddle) with sinker 100 0.1 N HCl 900 10, 15, 20, 30, 45 and 60 09/03/2015
Niraparib Capsule II (Paddle) with sinker 50 Tier 1: 0.08M Sodium Acetate Buffer, pH 4.0; Tier 2: 0.08M Sodium Acetate Buffer, pH 4.0 containing pepsin (750,000 units/L) 900 10, 15, 20, 30, 45 and 60 11/02/2017
Niraparib Tosylate Tablet II (Paddle) 60 0.1 M Citrate buffer, pH 4.6 900 5, 10, 15, 20, 25, 30 and 45 02/05/2024
Nisoldipine Tablet (Extended Release) II (Paddle) with option to use a sinker 50 HCl with SLS (32.5 ± 0.1 g Sodium Lauryl Sulfate in 6489 mL of purified water containing 17.0 mL HCl, pH adjusted to 1.20 ± 0.05 with HCl) 900 1, 4, 8, 12, 15, 18 and 24 hours 04/02/2009
Nitazoxanide Tablet II (Paddle) 75 Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC 900 10, 20, 30, 45, 60 01/03/2007
Nitazoxanide Oral Suspension II (Paddle 100 Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC  900 10, 20, 30, 45 and 60  10/21/2010
Nitisinone Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 2 mg tablets: 500 mL; 5 mg and 10 mg tablets: 900 mL 10, 15, 20, 30, 45, 60, 75 and 90 02/15/2018
Nitisinone Capsule II (Paddle) with sinker 50 Phosphate Buffer, pH 6.8 1000 5, 10, 15, 20, 30 and 45 11/02/2017
Nitisinone Suspension II (Paddle) 50 pH 1.2 HCl Buffer (degassed) 1000 10, 15, 20, 30 and 45 12/22/2016
Nitrofurantoin Capsule Refer to USP 04/02/2009
Nitrofurantoin Suspension II (Paddle) 50 Phosphate Buffer, pH 7.2 900 15, 30, 60, 120 and 180 04/02/2009
Nitroglycerin Tablet (Sublingual) II (Paddle) 50 Phosphate Buffer, pH 6.5 500 1, 3, 5, 8, and 10 01/15/2010
Nitroglycerin Film, Transdermal (Extended Release) Modified USP Type V (Paddle-over-disk) 100 Deionized Water at 32º C 900 10, 20, 30, 45, 60, 90, 120 and 180 04/08/2010
Nizatidine Capsule Develop a dissolution method 01/03/2024
Norethindrone Tablet Refer to USP 10/08/2009
Norethindrone Acetate Tablet Refer to USP 08/27/2009
Nortriptyline HCl Capsule Develop a dissolution method 01/03/2024
Nystatin Oral Suspension Develop a dissolution method 09/15/2023
Nystatin Tablet Develop a dissolution method 09/15/2023
Obeticholic Acid Tablet II (Paddle) 75 0.08% polysorbate 80 in 50mM sodium phosphate dibasic buffer, pH 6.8 900 5, 10, 15, 20, 30 and 45 11/02/2017
Octreotide Acetate Capsule (Delayed Release) II (Paddle with sinker) 50 Acid stage: 0.1N HCl ; Buffer stage: pH 6.8 buffer Acid stage: 900; Buffer stage: 900 Acid stage: 120; Buffer stage: 10, 20, 30 45 and 60 04/22/2021
Octreotide Injection Injectable (Extended Release)  Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency  12/23/2010
Ofloxacin Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Olanzapine Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Olanzapine Tablet (Orally Disintegrating) Refer to USP 01/15/2015
Olanzapine Pamoate For Intramuscular Suspension (Extended Release) IV (Flow through cell), 22.6 mm cell Flow @ 3 mL/min 1% SLS in pH 6.8 Phosphate Buffer use Open Mode 10, 20, 30, 45, 60, 75, 90, 105, 120, 150, 180, 240, 360, 480, 600, and 720 12/24/2015
Olanzapine; Samidorphan L-malate Tablet Refer to FDA's Dissolution Guidance, 2018 05/18/2023
Olaparib Tablet I (Basket) 100 50 mM Phosphate Buffer, pH 6.8 900 15, 30, 45 and 60 02/16/2024
Olmesartan Medoxomil Tablet Refer to USP 11/02/2017
Olsalazine Sodium Capsule I (Basket) 100 Phosphate Buffer, pH 7.5 900 10, 20, 30 and 45 02/12/2004
Olutasidenib Capsule II (Paddle) with sinkers 65 McIlvaine Buffer, pH 2.2 W/ 1.25% SDS 500 10, 15, 30, 45, and 60 02/05/2024
Ombitasvir/ Paritaprevir/ Ritonavir and Dasabuvir Sodium Tablet II (Paddle) 75 Ombitasvir, paritaprevir, ritonavir: 0.05 M sodium phosphate buffer, pH 6.8 with 0.3% polyoxyethylene 10 lauryl ether; Dasabuvir sodium: 0.05 M Sodium Phosphate buffer, pH 6.8 with 15 mM cetyl triethylammonium bromide (CTAB) 900 Ombitasvir, paritaprevir, ritonavir: 10, 20, 30, 45, 60, 90, 120 and 150; Dasabuvir: 5, 10, 15, 20 and 30 08/27/2015
Ombitasvir/Paritaprevir/Ritonavir Tablet  II (Paddle) with sinker  75 0.05M Sodium Phosphate Buffer, pH 6.8 with 0.3% (w/v) Polyoxyethylene 10 Lauryl Ether (POE10LE) 900 10, 20, 30, 45, 60, 90, 120, 150 and 180 06/30/2016
Omega-3-Acid Ethyl Esters Capsule  Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate pharmacopoeial apparatus, for comparative evaluation by the Agency.  03/17/2016
Omeprazole Capsule (Delayed Release) Refer to USP 06/18/2007
Omeprazole OTC Tablet (Delayed Release)  II (Paddle)  100 Tablets are pre-exposed to 750 ml of 0.1M HCL for 2 hrs and then 250 ml of 0.2M Na3PO4 is added to the medium to give 1000 ml with pH 6.8  Acid stage: 750; Buffer stage: 1000   Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60   02/28/2013
Omeprazole (Orally Disintegrating) OTC Tablet (Delayed Release)  II (Paddle) 100 Tablets are pre-exposed to 500 ml of 0.1M HCL for 2 hrs and then 400 ml of 0.235M Na2HP04 is added to the medium. Adjust if necessary with 2 N HCI or 2 N NaOH to a pH of 6.8  Acid stage: 500; Buffer stage: 900   Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60   02/08/2018
Omeprazole Magnesium For suspension (Delayed Release) II (Paddle) 100 Pre-exposed to 300 mL of 0.1M HCl for 2 hrs and then 700 mL of 0.086 M Na2HPO4 is added to the medium to give 1000 mL with pH 6.8 Acid stage: 300; Buffer stage: 1000   Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60   02/07/2019
Omeprazole Magnesium Capsule, Delayed Release II (Paddle) 100 Acid stage: 0.1 N HCl (deaerated) for 2 hrs; Buffer stage: Phosphate buffer (deaerated), pH 6.8 Acid stage: 120; Buffer stage: 10, 20, 30 and 45 03/30/2023
Omeprazole Magnesium OTC Tablet (Delayed Release) II (Paddle) 100 Tablets are pre-exposed to 300 mL of 0.1M HCL for 2 hrs and then 700 mL of 0.086 M Na2HPO4 is added to the medium containing the capsule to give 1000 mL with pH 6.8 300 ml for the acid stage; 1000 ml for the buffer stage Sampling started at the buffer stage 10, 20, 30, 45 and 60 01/03/2007
Omeprazole Sodium Bicarbonate Powder for suspension (Immediate Release) II (Paddle) 50 0.25 mM Sodium Phosphate Buffer, pH 7.4 900 5, 10, 15, and 30 06/20/2007
Omeprazole Sodium Bicarbonate Capsule II (Paddle) 75 Phosphate Buffer, pH 7.4 900 15, 30, 45 and 60 07/14/2008
Ondansetron Tablet (Orally Disintegrating) Refer to USP 06/18/2007
Ondansetron Film (Oral) V (Paddle over Disk) with a stainless steel disk (120 mesh screens) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 01/26/2012
Ondansetron HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Opicapone Capsule I (Basket with sinker) 100 Tier 1: 0.05 M Phosphate Buffer, pH 6.8 with 1% cetrimide; Tier 2: Stage 1: 0.05 M Phosphate Buffer, pH 6.8 with pancreatin (1750 USP units/L); Stage 2: after 10 minutes of Stage 1, add 100 mL of 10% cetrimide. 5, 10, 15, 20, 30 and 45 05/12/2022
Orlistat Capsule II (Paddle) 75 3% SLS in 0.5% Sodium Chloride, pH 6.0 900 10, 20, 30, 45 and 60 02/12/2004
Orphenadrine Citrate Tablet (Extended Release)  Develop a dissolution method 01/03/2024
Oseltamivir Phosphate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Oseltamivir Phosphate Oral Suspension II (Paddle)  25 0.1 N HCl 900 5, 10, 15, 20 and 30 07/15/2009
Osilodrostat Phosphate Tablet Refer to FDA's Dissolution Guidance, 2018 08/19/2021
Osimertinib Mesylate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Ospemifene Tablet Develop a dissolution method 09/15/2023
Oteseconazole Capsule II (Paddle) with sinker 75 Tier 1: Stage 1: 0.01N HCl; Stage 2: After 15 minutes, add 150 mL of 3.0% SLS Tier 2: Stage 1: Pepsin (750,000 units/L) in 0.01N HCl; Stage 2: After 15 minutes, add 150 mL of 3.0% SLS 20, 30, 45 and 60 10/06/2023
Oxandrolone Tablet Refer to USP 02/09/2023
Oxaprozin Tablet  Refer to USP 03/17/2016
Oxcarbazepine Suspension Develop a dissolution method 09/15/2023
Oxcarbazepine Tablet Develop a dissolution method 09/15/2023
Oxcarbazepine Tablet (Extended Release)   Develop a dissolution method 09/15/2023
Oxybutynin Trans-dermal Paddle over Disk (Apparatus 5) 50 Phosphate Buffer, pH 4.5 @ 32oC 900 1, 4, 24 hours 01/03/2007
Oxybutynin Chloride Tablet (Extended Release) Refer to USP 12/24/2015
Oxycodone Capsule (Extended Release)  I (Basket) 100 22 mM Sodium Acetate buffer, pH 4.5 with 0.03% Tween 20 900 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 07/28/2016
Oxycodone HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Oxycodone HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Oxycodone HCl Tablet (Extended Release)  Refer to USP 03/17/2016
Oxycodone HCl/ Naloxone HCl Tablet (Extended Release)   II (Paddle) 50 Simulated Gastric Fluid [SGF, pH 1.2] without enzyme 900 0.25, 0.5, 1, 2, 4, 6, 8, 10 and 12 hours 12/22/2016
Oxymorphone HCl Tablets Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Oxymorphone HCl Tablet (Extended Release)  II (Paddle) with sinker 50 45 mM Phosphate Buffer, pH 4.5 900 1, 2, 4, 6, 8 and 10 hours 02/14/2014
Ozanimod HCl Capsule Refer to FDA's Dissolution Guidance, 2018 05/12/2022
Pacritinib Citrate Capsule II (Paddle) with sinker 75 0.08 M HCl/0.034 M NaCl, pH 1.2 900 5, 10, 15 and 30 05/18/2023
Palbociclib Tablet II (Paddle)  75 0.1 N HCl 900 10, 15, 20, 30 and 45 08/19/2021
Palbociclib Capsule  II (Paddle) with sinker 50 0.1 N HCl 900 10, 15, 20, 30 and 45 03/17/2016
Paliperidone Tablet (Extended Release)  II (Paddle) 50 Modified SGF, pH 1.0 [NaCl (0.2% w/w) in 0.0825N HCl] 500 1, 2, 4, 6, 8, 12, 14, 18 and 24 hours 08/27/2009
Paliperidone Palmitate Intramuscular Suspension (Extended Release) II (Paddle) 50 0.489% (w/v) Polysorbate 20 in 0.001 N HCl @25.0 °C. 900 1.5, 5, 8, 10, 15, 20, 30 and 45 09/01/2011
Paliperidone Palmitate [3-month injection] Intramuscular Suspension (Extended Release)  II (Paddle) 50 0.489% (w/v) Polysorbate 20 in 0.001 N HCl @25.0 °C. 900 5, 30, 60, 90, 120, 180, 240, 300 and 360 03/17/2016
Palonosetron HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Pancrelipase Capsule (Delayed Release)  Refer to USP 03/17/2016
Pancrelipase Tablet II (Paddle)  50 Phosphate Buffer, pH 4.5 900 10, 20, 30, 45 and 60  06/02/2016
Panobinostat Lactate Capsule   Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Pantoprazole Sodium Delayed Release Granules for Oral Suspension II (Paddle) 100 Acid Stage: 0.1 N Hydrochloric Acid; Buffer Stage: 0.05 M Tribasic Sodium Phosphate (Add 250 mL of 0.2 mM Tribasic Sodium Phosphate after completion of acid stage); pH 6.8 (Method B) Acid stage: 750; Buffer stage: 1000  Acid stage: 60, 90 and 120; Buffer stage: 10, 20, 30, 45 and 60  10/30/2009
Pantoprazole Sodium Tablet (Delayed Release)  Refer to USP 07/21/2009
Paricalcitol Capsule I (Basket) 100 4 mg/mL (0.4%) Lauryldimethylamine N-oxide (LDAO) 500 20, 30, 45, 60 06/18/2007
Paromomycin Sulfate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Paroxetine Tablet (Extended Release) Refer to USP 11/19/2015
Paroxetine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Paroxetine HCl Suspension II (Paddle) 100 SGF without enzyme 900 10, 20, 30 and 45 02/13/2004
Paroxetine Mesylate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Paroxetine Mesylate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Patisiran Sodium Solution II (Paddle) 25 Tris/EDTA buffer, pH 7.5 with 0.02% Tween 20 500 2, 5, 7, 11 and 15 03/30/2023
Pazopanib HCl Tablet II (Paddle) 75 50 mM Sodium Acetate buffer, pH 4.5, containing 0.75% SDS 900 10, 15, 30, 45 and 60 08/05/2010
Pemigatinib Tablet I (Basket) 50 0.01 N HCl 500 5, 10, 15, 20, 30 and 45 05/12/2022
Pemoline Tablet Develop a dissolution method 09/15/2023
Penbutolol Sulfate Tablet Refer to USP 06/24/2010
Penicillamine Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Penicillin G Benzathine Injectable Develop a method to characterize in vitro release 08/19/2021
Penicillin V Tablet  Refer to USP  06/09/2011
Penicillin V Potassium Tablet  Refer to USP  06/09/2011
Pentosan Polysulfate Sodium Capsule Develop a dissolution method 09/15/2023
Pentoxifylline Tablet (Extended Release)   Develop a dissolution method 01/03/2024
Perampanel Suspension II (Paddle) 50 0.1 N HCl 900 [890 mL 0.1 N HCl + 10 mL perampanel suspension] 5, 10, 15, 20 and 30 12/22/2016
Perampanel Tablet II (Paddle)  50 0.1 N HCl  900 5, 10, 15, 20 and 30 05/15/2014
Pergolide Mesylate Tablet II (Paddle) 50 Simulated gastric fluid TS with cysteine without enzymes 500 10, 20, 30 and 45 03/04/2006
Perindopril Erbumine Tablet II (Paddle) 50 0.1 N HCl 900 10, 20 , 30 and 45 06/20/2007
Perphenazine Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Phendimetrazine Tartrate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Phendimetrazine Tartrate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Phendimetrazine Tartrate Capsule (Extended Release) II (Paddle) 50 1 hour - SGF w/o Enzymes; after 1 hour - SIF w/o Enzymes 900 1, 2, 4, 6 and 8 hours 06/10/2009
Phenelzine Sulfate Tablet II (Paddle)  50 Simulated Gastric Fluid without enzymes, pH 1.2  900  10, 20, 30 and 45  03/25/2010
Phenoxybenzamine HCl Capsule Refer to USP 04/10/2008
Phentermine HCl Tablet (Orally Disintegrating)  Develop a dissolution method 09/15/2023
Phentermine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Phentermine HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Phentermine HCl/Topiramate Capsule (Extended Release)  Develop a dissolution method 09/15/2023
Phenytoin Suspension Refer to USP 06/18/2007
Phenytoin Tablet (Chewable) Develop a dissolution method 01/03/2024
Phenytoin Sodium Capsule Develop a dissolution method 01/03/2024
Phytonadione Tablet Develop a dissolution method    03/25/2010
Pilocarpine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Pimavanserin Tartrate Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Pimozide Tablet Refer to USP 02/19/2008
Pindolol Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Pioglitazone HCl Tablet II (Paddle) 75 HCl-0.3 M KCl Buffer, pH 2.0 900 5, 10, 15 and 30 02/13/2004
Pirfenidone Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Pirfenidone Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Piroxicam Capsule Refer to USP 10/04/2012
Pitavastatin Calcium Tablet  I (Basket) 35 0.05 M Phosphate Buffer, pH 6.8 900 5, 10, 15, 20, 30 and 45  12/23/2010
Pomalidomide Capsule II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 45 05/28/2015
Ponatinib HCl Tablet I (Basket) 50 pH 2.1, KCl/HCl buffer (degassed) 900 10, 15, 20, 30, 45 and 60 09/03/2015
Posaconazole Tablet (Delayed Release) II (Paddle) 75 Acid Stage: 0.01 N HCl: Buffer Stage: 50 mM phosphate buffer, pH 6.8 with 0.37 % Polysorbate 80 (after 120 minutes, to the acid stage, add 250 mL of 0.2M Phosphate Buffer, 1.46% Polysorbate 80) Acid Stage: 750 mL; Buffer Stage 1000 mL Acid Stage: 120; Buffer Stage: 10, 15, 20, 30 and 45 06/25/2015
Posaconazole For Suspension (Delayed Release) II (Paddle) 75 Acid stage: 0.01 N HCl; Buffer stage: pH 6.8 Phosphate buffer with 1.3% Tween 80; Acid stage: 750 mL; Buffer stage: 1000 mL Acid stage: 120; Buffer stage: 5, 10, 15, 20, 30 and 45 07/07/2022
Posaconazole Oral Suspension II (Paddle) 25 0.3% SLS 900 10, 20, 30 and 45 12/03/2007
Potassium Chloride Tablet (Extended Release) Develop a dissolution method 01/03/2024
Potassium Chloride Capsule (Extended Release)  Develop a dissolution method 01/03/2024
Potassium Citrate Tablet Develop a dissolution method 01/03/2024
Pralsetinib Capsule II (Paddle) with sinker 50 50 mM Sodium Phosphate Buffer, pH 6.8, with 0.4% w/v Cetyl Trimethylammonium Bromide (CTAB) 900 10, 20, 30, 45 and 60 07/07/2022
Pramipexole Dihydrochloride Tablet (Extended Release)  I (Basket) 100 0.05 M phosphate buffer, pH 6.8 500 1, 2, 4, 6, 9, 12, 16, 20 and 24 hours 09/02/2010
Pramipexole Dihydrochloride Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Prasugrel HCl Tablet  II (Paddle) 75 Citrate-Phosphate buffer (0.023M Citric acid+0.026M Sodium Phosphate, Dibasic), pH 4.0  900 10, 15, 20, 30 and 45  10/04/2012
Pravastatin Sodium Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Praziquantel Tablet Refer to USP 06/25/2015
Prazosin HCl Capsule Refer to USP 05/12/2022
Prednisolone Tablet Develop a dissolution method 01/03/2024
Prednisolone Acetate Ophthalmic Suspension   Develop an in vitro release method 05/15/2014
Prednisolone Sodium Phosphate Tablet (Orally Disintegrating) II (Paddle) 50 22 mM Sodium Acetate Buffer, pH 4.5 500 5, 15, 30, 45 and 60 09/03/2008
Prednisone Tablet Develop a dissolution method 01/03/2024
Prednisone Tablet (Delayed Release)  Develop a dissolution method 09/15/2023
Pregabalin Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Pregabalin Tablet (Extended Release) II (Paddle) 50 0.06 M HCl 900 1, 2, 4, 6, 8, 10, 12, 16 and 24 hours 02/08/2018
Pretomanid Tablet II (Paddle) 75 0.1 N HCl with 0.5% hexadecyltrimethylammonium (HDTMA) 1000 5, 10, 15, 20, 30 and 45 04/22/2021
Primaquine Phosphate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Primidone Tablet Develop a dissolution method 01/03/2024
Primidone Tablet Develop a dissolution method 11/30/2023
Procarbazine HCl Capsules Develop a dissolution method 09/15/2023
Prochlorperazine Rectal Suppository I (Suppository, dissolution baskets, palmieri type) 100 0.1 N HCl at 38° C 900 10, 20, 30 and 45  08/17/2006
Prochlorperazine Maleate Tablet II (Paddle) 75 0.1 N HCl 500 10, 20, 30, 45, 60, 75, and 90 04/22/2021
Progesterone Gel I (Basket) with Diacell sample holder 100 Methanol:water 20:80 1000 2, 4, 8, 12, 20, 24, 48 and 72 hours 03/30/2023
Progesterone Vaginal Insert II (Paddle) 50 0.25% sodium dodecyl sulfate (SDS) in DI water 900 5, 10, 15, 20 and 30  10/04/2012
Progesterone Capsule Develop a quantitative rupture test  04/08/2010
Promethazine HCl Rectal Suppository  Develop a method to characterize in vitro release 10/20/2016
Promethazine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Propafenone HCl Tablet Refer to USP 11/02/2017
Propafenone HCl Capsule (Extended Release) Refer to USP 11/02/2017
Propranolol HCl Tablet Refer to FDA's Dissolution Guidance, 2018 04/22/2021
Propranolol HCl Capsule (Extended Release) Refer to USP 07/25/2007
Propylthiouracil Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Protriptyline HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Protriptyline HCl Tablet Develop a dissolution method 01/03/2024
Prucalopride Succinate Tablet Refer to FDA's Dissolution Guidance, 2018 04/22/2021
Pseudoephedrine HCl Tablet (Extended Release) Develop a dissolution method 01/03/2024
Pseudoephedrine HCl/Triprolidine HCl Tablet Develop a dissolution method 01/03/2024
Pyrazinamide Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Pyridostigmine Bromide Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Pyridostigmine Bromide Tablet (Extended Release) Develop a dissolution method 09/15/2023
Pyrimethamine Tablet Refer to USP 06/25/2015
Quetiapine Fumarate Tablet (Extended Release) I (Basket, with 20 mesh)  200 0.05M citric acid and 0.09 N NaOH (pH 4.8) [solution A]. At 5 hrs, pH adjusted to 6.6 by addition of 100 mL of 0.05M dibasic sodium phosphate and 0.46N NaOH [solution B]  900 [solution A]. 1000 [final]  1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 hours  01/31/2013
Quetiapine Fumarate Tablet Develop a dissolution method 09/15/2023
Quinapril HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Quinidine Gluconate Tablet (Extended Release) Refer to USP 04/22/2021
Quinine Sulfate Capsule Refer to USP 01/14/2008
Rabeprazole Sodium Capsule (Delayed Release) II (Paddle) Acid Stage: 75 rpm; Buffer Stage: 60 rpm Acid Stage:0.1 N HCl; Buffer Stage: 0.05 M Phosphate Buffer, pH 6.8 (After Acid Stage, add 250 mL of 0.2 mol/L trisodium phosphate solution). Acid Stage: 750; Buffer Stage:1000 Acid Stage: 120; Buffer Stage: 10, 15, 20, 25, 30 and 45 05/15/2014
Rabeprazole Sodium Tablet (Delayed Release) II (Paddle) 100  700 mL 0.1 N HCl (Acid stage), after two hours add 300 mL of 0.6 M Tris buffer; adjust to pH 8.0 (Buffer stage) with 2 N HCl or 2 N NaOH . Stabilize the samples with the addition of 0.5 N NaOH  Acid stage: 700; Buffer stage: 1000  Acid stage: 120; Buffer stage: 10, 20, 30, and 45   09/22/2011
Raloxifene HCl Tablet Develop a dissolution method 09/15/2023
Raltegravir Potassium Tablet (Chewable) Develop a dissolution method 09/15/2023
Raltegravir Potassium Tablet Develop a dissolution method 09/15/2023
Ramelteon Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Ramipril Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Ramipril Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Ranitidine HCl Tablet Develop a dissolution method 01/03/2024
Ranitidine HCl Capsule Develop a dissolution method 09/15/2023
Ranitidine HCl Tablet (Effervescent) Develop a dissolution method    04/08/2010
Ranolazine Granules (Extended Release) II (Paddle) 50 0.1 N HCl 900 0.5, 1, 2, 3, 4, 6 and 8 hours 07/07/2022
Ranolazine Tablet (Extended Release) Develop a dissolution method    02/07/2019
Rasagiline Mesylate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Regorafenib Tablet II (Paddle) 75 Acetate Buffer pH 4.5 with 0.1% Sodium Dodecyl Sulfate (SDS) 900 10, 15, 20, 30 and 45 06/25/2015
Relugolix Tablet II (Paddle) 50 50 mM Citrate Buffer, pH 5.5 900 5, 10, 15, 20 and 30  07/07/2022
Repaglinide Tablet Refer to USP 07/25/2007
Ribavirin Tablet Develop a dissolution method 09/15/2023
Ribavirin Capsule Develop a dissolution method 09/15/2023
Ribociclib Tablet II (Paddle) 50 0.01N HCl (degassed) 900 10, 20, 30, 45 and 60 05/12/2022
Rifabutin Capsule Refer to USP 12/15/2009
Rifampin Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Rifamycin Sodium Tablet (Delayed Release) II (Paddle) 100 Acid stage: HCl 0.1 N with 0.5% w/v Macrogol Cetostearyl Ether; Buffer stage: pH 7.2 Sodium Phosphate buffer Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours 04/22/2021
Rifapentine Tablet II (Paddle) 50 0.8% SLS in Phosphate Buffer, pH 7.0 900 10, 20, 30, 45, 60 and 90 02/25/2004
Rifaximin (200 mg) Tablet  II (Paddle)  75 0.1M sodium phosphate buffer pH 7.4 containing 0.45% Sodium Lauryl Sulfate 1000 10, 20, 30, 45, 60, 90 and 120  07/21/2011
Rifaximin (550 mg) Tablet  II (Paddle)  75 0.1M sodium phosphate buffer pH 7.4 containing 0.8% Sodium Lauryl Sulfate 1000 10, 20, 30, 45, 60, 90 and 120  07/21/2011
Rilpivirine HCl Tablet  II (Paddle) 75 0.5% Polysorbate 20 in 0.01N HCl (pH=2.0) 900 10, 20, 30, 45 and 60 08/15/2013
Riluzole Suspension II (Paddle) 35 Phosphate Buffer pH 4.5 900 [890 mL of medium + 10 mL of suspension] 5, 10, 20, 30, 45 and 60 05/12/2022
Riluzole Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 02/18/2004
Rimantadine HCl Tablet Develop a dissolution method 09/15/2023
Rimegepant Sulfate Tablet, (Orally Disintegrating (ODT)) II (Paddle) 50 50 mM Sodium Acetate Buffer, pH 4.5 500 5, 10, 15, 20 and 30 05/12/2022
Rimexolone Ophthalmic Suspension Develop a method to characterize in vitro release 06/30/2016
Riociguat Tablet II (Paddle) 75 pH 6.8 Phosphate Buffer with 0.1% Sodium Lauryl Sulfate [SLS] 900 5, 10, 15, 20 and 30 12/24/2015
Ripretinib Tablet II (Paddle) 75 10 mM Sodium Acetate Buffer, pH 4.5, containing 0.25% (w/v) sodium dodecyl sulfate (SDS) 900 5, 10, 15, 20, 30 and 45 05/12/2022
Risedronate Sodium Tablet Develop a dissolution method 01/03/2024
Risedronate Sodium Tablet (Delayed Release)  II (Paddle)  75 Acid stage: 0.1 N HCl; Buffer stage: Phosphate buffer, pH 6.8    Acid stage: 500; Buffer stage: 500   Acid stage: 120; Buffer Stage: 10, 15, 20, 30 and 45 01/26/2012
Risedronate Sodium/Calcium Carbonate Tablet (Copackaged)  For Risedronate Tablets: Refer to USP; For Calcium Carbonate Tablets: Refer to USP. 07/01/2010
Risperidone Suspension (Extended Release) Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 01/15/2010
Risperidone Tablet II (Paddle) 50 0.1 N HCl 500 10, 20, 30, 45 and 60 03/04/2006
Risperidone Tablet (Orally Disintegrating) II (Paddle) 50 0.1 N HCl 500 5, 10, 15 07/23/2004
Ritonavir Tablet Refer to USP 01/15/2015
Ritonavir Capsule Refer to USP 01/15/2015
Ritonavir Powder I (Basket -100 mesh) 100 0.1 N HCl 900 5, 10, 15, 20 and 30 11/16/2017
Rivaroxaban (10 mg) Tablet  II (Paddle) 75 Acetate Buffer pH 4.5, 0.2% sodium dodecyl sulfate (SDS) 900 10, 15, 20, 30 and 45 01/15/2015
Rivaroxaban (15 and 20 mg) Tablet  II (Paddle) 75 Acetate Buffer pH 4.5, 0.4% SDS 900 10, 15, 20, 30 and 45 01/15/2015
Rivaroxaban (2.5 mg) Tablet  II (Paddle) 75 Acetate Buffer pH 4.5 900 10, 15, 20, 30 and 45 02/07/2019
Rivastigmine Film, Transdermal Modified USP Type VI (cylinder) 50 0. 9 % NaCl at 32º C 500 1, 2, 4, 7, 9 and 12 hours 06/10/2009
Rivastigmine Tartrate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Rizatriptan Benzoate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Rizatriptan Benzoate Tablet, (Orally Disintegrating (ODT)) Develop a dissolution method 01/03/2024
Roflumilast Tablet  II (Paddle) 50 1.0% SDS (sodium dodecyl sulfate) in Phosphate Buffer, pH 6.8 1000 5, 10, 15, 20, 30 and 45 08/15/2013
Rolapitant HCl Tablet II (Paddle) 50 0.05 M Sodium Acetate buffer, pH 4.0 900 10, 15, 20, 30 and 45 10/20/2016
Ropinirole HCl Tablet (Extended Release)  II (Paddle) 100 pH 4.0 Citrate-THAM Buffer 500 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 08/27/2009
Ropinirole HCl Tablet Refer to USP  05/15/2014
Rosuvastatin Calcium Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Rotigotine Transdermal Paddle over Disk (Apparatus 5)  50 Phosphate Buffer, pH 4.5 at 32°C 900 15, 30, 60, 90, 120, 150 and 180 07/15/2009
Rucaparib Tablet  II (Paddle) 75 0.01 N HCl 900 5, 10, 15, 20 and 30  01/19/2017
Rufinamide Tablet  Refer to USP  08/15/2013
Rufinamide Suspension Develop a dissolution method 09/15/2023
Ruxolitinib Phosphate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Sacubitril/Valsartan Tablet  I (Basket) 75 Phosphate Buffer, pH 6.8[degassed] 900 10, 15, 20, 30 and 45 10/24/2019
Safinamide Mesylate Tablet II (Paddle) 100 0.1 N HCL with Sodium Chloride [0.2% (wt/vol) solution], pH 1.2 900 5, 10, 15, 30, 45 and 60 10/06/2023
Sapropterin Dihydrochloride Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Saquinavir Mesylate Tablet II (Paddle) 50 Citrate Buffer (pH 3.0) 900 10, 20 , 30 and 45 09/13/2007
Saquinavir Mesylate Capsule Refer to USP 09/13/2007
Saxagliptin HCl Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Scopolamine Transdermal Reciprocating disk (Apparatus 7) Stroke depth: 2-3 cm; 30-60 cycles per minute Distilled Water 25 × 150 mm test-tubes containing 20 mL 1, 2, 4, 6, 12, 18, 24, 36, 48, and 72 hours 07/15/2009
Secnidazole Granule I (Basket) 50 Phosphate Buffer, pH 6.8 900 0.5, 1, 1.5, 2, 2.5, 3, 3.5 and 4 hours 11/16/2017
Selegiline HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Selegiline (20 mg/20 cm2 and 30 mg/30 cm2) Transdermal Paddle over Disk (Apparatus 5)  50 0.1 M Phosphate buffer, monobasic, pH 5 at 32°C 500 1, 2, 4, 8, 12, 16, 20 and 24 hours 07/15/2009
Selegiline (40 mg/40 cm2) Transdermal Rotating Cylinder (Apparatus 6) 50 0.1 M Phosphate buffer, monobasic, pH 5 at 32°C 1000 1, 2, 4, 8, 12, 16, 20 and 24 hours 07/15/2009
Selegiline HCl Tablet (Orally Disintegrating) Develop a dissolution method 09/15/2023
Selexipag Tablet  II (Paddle) 50 Phosphate Buffer, pH 6.8 900 5, 10, 15, 20 and 30 03/17/2016
Selinexor Tablet II (Paddle) 75 10 mM Citric Acid Buffer, pH 4.5 with 0.5% SDS 900 10, 15, 20, 30 and 45 08/19/2021
Selpercatinib Capsule II (Paddle) 75 0.1N HCl 900 5, 10, 15, 20 and 30  07/07/2022
Selumetinib Capsule II (Paddle) with sinker 75 Sodium Phosphate Buffer, pH 6.5, with 0.5% Polysorbate 80 1000 10, 20, 30, 45 and 60 07/07/2022
Semaglutide Tablet II (Paddle) 70 50 mM Phosphate Buffer with 0.05% Brij 35 (polyoxyethylene lauryl ether), pH 6.8 500 10, 15, 20, 30, 45, 60 and 75 08/19/2021
Sertraline HCl Capsule II (Paddle) with sinker 75 0.1 N HCl 900 10, 15, 20, 30 and 45 07/07/2023
Sertraline HCl Tablet II (Paddle) 75 0.05 M Sodium Acetate Buffer, pH 4.5 900 10, 20, 30 and 45 02/20/2004
Sevelamer Carbonate Tablet Disintegration Testing in 0.1 N HCl as per USP <701>  10/06/2008
Sevelamer HCl Capsule Disintegration Testing in 0.1 N HCl as per USP <701> 04/09/2008
Sevelamer HCl Tablet Disintegration Testing in 0.1 N HCl as per USP <701> 04/09/2008
Sibutramine HCl Capsule II (Paddle) 50 0.05 M Acetate Buffer, pH 4.0 500 10, 20, 30, 45 and 60 02/25/2004
Sildenafil Citrate Tablet I (Basket) 100 0.01 N HCl 900 5, 10, 15 and 30 03/04/2006
Sildenafil Citrate Suspension II (Paddle) 50 McIlvaine Buffer, pH 5.0 500 5, 10, 15, 20 and 30 05/28/2015
Silodosin Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Simeprevir Sodium Capsule II (Paddle) 75 0.05 M Phosphate Buffer, pH 6.8 with 1.0% polysorbate 20 900 10, 15, 20, 30 and 45 05/28/2015
Simvastatin Suspension II (Paddle) 50 Phosphate Buffer, pH 7.0, with 0.14% sodium dodecyl sulfate (SDS) 900 10, 15, 20, 30 and 45 12/22/2016
Simvastatin Tablet Refer to USP 06/18/2007
Simvastatin Tablet (Orally Disintegrating) II (Paddle) 75 0.15% SDS Buffer, pH 6.8 900 5, 10, 15 and 30 09/03/2008
Siponimod Fumaric Acid Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 with 0.1% (m/v) Polysorbate 80 900 mL [for 2 mg strength] 500 mL [for 0.25 mg strength] 5, 10, 15, 20 and 30 08/19/2021
Sirolimus Tablet Develop a dissolution method 09/15/2023
Sirolimus Gel Develop a method to characterize in vitro release 05/18/2023
Sitagliptin Phosphate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Sitagliptin Phosphate/Simvastatin Tablet II (Paddle) with stainless steel stationary quadrangular hanging basket 100 10 mM Sodium phosphate buffer containing 1% Tween 80 with 50 μg/mL Butylated hydroxyanisole 900 5, 10, 15, 20, 30, and 45 10/31/2013
Sodium Iodide I-123 Capsule Develop a dissolution method 09/15/2023
Sodium Iodide I-131 Capsule Develop a dissolution method 07/07/2022
Sodium Phenylbutyrate Pellets II (Paddle) 75 Simulated Intestinal Fluid without pancreatin 900 5, 10, 15, 30 and 45 02/05/2024
Sodium Phenylbutyrate Powder for Oral II (Paddle) 75 Simulated Intestinal Fluid 900 15, 30, 45, 60 and 90 04/02/2009
Sodium Phenylbutyrate; Taurursodiol Powder II (Paddle) 75 5 mM phosphate w/ 0.1% SDS, pH 6.8 900 5, 10, 15, 30 and 45 02/05/2024
Sodium Phosphate Dibasic Anhydrous/Sodium Phosphate Monobasic Monohydrate Tablet Develop a dissolution method 09/15/2023
Sofosbuvir Pellets II (Paddle) 75 25 mM Potassium Phosphate Buffer, pH 5.5 900 5, 10, 15, 20, 30 and 45 08/19/2021
Sofosbuvir Tablet II (Paddle) 75 0.05 M Phosphate Buffer, pH 6.8 900 5, 10, 15, 20 and 30 08/19/2021
Sofosbuvir/Velpatasvir Tablet II (Paddle) 75 50 mM sodium acetate buffer,pH 5.0, with 0.5% w/v Cetyltrimethyl ammonium bromide (CTAB) 900 5, 10, 15, 20 and 30 10/20/2016
Solifenacin Succinate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Solifenacin Succinate Suspension II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30  07/07/2022
Solriamfetol HCl Tablet I (Basket) 100 0.1 N HCl 900 5, 10, 15, 20 and 30 08/19/2021
Sonidegib Phosphate Capsule  II (Paddle) with sinker 75 Tier 1: 0.1 M HCl with 1.0% SDS; Tier II: Stage 1: 850 mL of 0.1 N HCl solution with pepsin [250’000 units/L]. Stage 2: After 10 minutes add 50 mL of 18% SDS in 0.1 N HCl Tier 1: 900; Tier 2: Stage 1: 850 mL, Stage 2: 900 mL 15, 30, 45, 60, and 90 03/17/2016
Sorafenib Tosylate Tablet II (Paddle) 75 0.1 M HCl with 1% SDS 900 5, 10, 15, 20 and 30 06/10/2009
Sotorasib Tablet II (Paddle) 75 120 mg: 50 mM phosphate buffer, pH 6.8 with 0.2% SLS; 320 mg: 50 mM phosphate buffer, pH 6.8 with 0.4% SDS 900 5,10,15, 20 and 30 11/30/2023
Spironolactone Tablet Refer to USP 04/15/2008
Stavudine Capsule Develop a dissolution method 01/03/2024
Succimer Capsule II (Paddle) 50 0.01 N Phosphoric Acid 900 10, 20, 30, 45, 60 and 90 02/20/2004
Sucralfate Suspension II (Paddle) 75 0.1N HCl/0.067 M KCl, pH 1.0 900 10, 20, 30 and 45 03/04/2006
Sucralfate Tablet II (Paddle) 75 0.1 N HCl/0.067 M KCl, pH 1.0 900 15, 30, 45, 60, 180, 240 and 480 04/02/2009
Sucroferric Oxyhydroxide Tablet (Chewable) II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30, 45 and 60 11/02/2017
Sufentanil Citrate Tablet (Sublingual) II (Paddle) 50 pH 4.5 Acetate Buffer 50 2, 4, 8, 12 and 15 05/12/2022
Sulfadiazine Tablet Refer to USP 07/14/2008
Sulfamethoxazole/Trimethoprim Tablet Refer to USP 01/14/2008
Sulfamethoxazole/Trimethoprim Suspension II (Paddle) 50 1 mL of 0.2 N HCl in water 900 10, 20, 30, 45, 60 and 90 02/25/2004
Sulfasalazine Tablet Refer to USP 12/15/2009
Sulfasalazine Tablet (Delayed Release)  Refer to USP 12/15/2009
Sulfisoxazole Acetyl Oral Suspension (Pediatric) II (Paddle) 30 1% SLS in 0.1N HCl 900 15, 30, 45, 60 and 90 08/17/2006
Sumatriptan Succinate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Sunitinib Malate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Suvorexant Tablet Develop a dissolution method 09/15/2023
Tacrolimus Tablet (Extended Release)   II (Paddle) 100 0.005% HPC in Water with 0.50% SLS adjusted to pH 4.5 900 0.5, 1, 2.5, 4.5, 6.5, 8.5 and 12 hours 06/30/2016
Tacrolimus Capsule II (Paddle) 50 Hydroxypropyl Cellulose Solution (1 in 20,000). Adjust to pH 4.5 by Phosphoric Acid 900 30, 60, 90 and 120 02/20/2004
Tacrolimus For Suspension II (Paddle) 50 Hydroxypropyl Cellulose Solution (1 in 20,000). Adjust to pH 4.5 by Phosphoric Acid 15, 30, 45, 60, 90 and 120 02/09/2023
Tadalafil Tablet II (Paddle) 50 0.5% Sodium Lauryl Sulfate 1000 10, 20, 30 and 45 01/26/2006
Tafamidis Capsule II (Paddle) with sinker 75 Tier 1 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8 with 1.0% Tween 80; Tier II Medium: 0.05M Sodium Phosphate Buffer, pH 6.8 with 1.0% Tween 80 and enzyme with protease activity as per USP 900 5, 10, 15, 20, 30 and 45 04/22/2021
Tafamidis Meglumine Capsule II (Paddle) with sinker 75 Tier 1 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8. Tier 2 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8, and pancreatin with protease activity as per USP 900 5, 10, 15, 20, 30 and 45 04/22/2021
Tafenoquine Succinate Tablet II (Paddle) 75 0.01M Sodium phosphate buffer, pH 6.8, with 0.20% w/v of Polysorbate 20 900 5, 10, 20, 30, 45 and 60 08/27/2020
Talazoparib Tosylate Capsule II (Paddle) with sinker 75 0.01 N HCl with 0.2% sodium dodecyl sulfate (SDS), 500 10, 15, 20, 30 and 45 08/27/2020
Tamoxifen Citrate Tablet Refer to USP 04/02/2009
Tamsulosin HCl Capsule II (Paddle) 100 0-2 hours: 0.003% polysorbate 80, pH 1.2 2-8 hours: phosphate buffer, pH 7.2 500 1, 2, 3, 6, 8, and 10 hours 03/26/2007
Tapentadol HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tapentadol HCl Tablet (Extended Release)  II (Paddle) with sinker  100 0.05 M Phosphate Buffer of pH 6.8, Simulated intestinal fluid (without enzyme)  900 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours   10/31/2013
Tasimelteon Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tazemetostat Hydrobromide Tablet II (Paddle) 50 0.01 N HCl 900 5, 10, 15, 20, 30 and 45 05/12/2022
Tedizolid Phosphate Tablet II (Paddle)  60 0.05 M phosphate buffer pH 6.8 900 5, 10, 15, 20 and 30 06/02/2016
Tegaserod Maleate Tablet Develop a dissolution method 09/15/2023
Telaprevir Tablet Develop a dissolution method 09/15/2023
Telbivudine Tablet II (Paddle) 50 0.1 N HCl 900 15, 30 and 45 04/02/2009
Telithromycin Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 01/03/2007
Telmisartan Tablet  Refer to USP  01/05/2012
Temazepam Capsule Refer to USP 01/14/2008
Temozolomide Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tenapanor Hydrochloride Tablet II (Paddle) 75 9.4 mM Citrate Buffer, pH 4 900 5, 10, 15, 20, 30 and 45 08/19/2021
Tenofovir Alafenamide Fumarate Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tenofovir Disoproxil Fumarate Powder for Oral  II (Paddle) 100 0.2% polysorbate 80 in 0.01 M HCl 900 10, 20, 30, 45, 60 and 75  01/31/2013
Tenofovir Disoproxil Fumarate Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, and 45  01/03/2007
Tepotinib HCl Tablet II (Paddle) 50 Acetate buffer, pH 4.5 + 1 mM NaCl + 0.1% polysorbate 80 900 5, 15, 20 and 35 03/30/2023
Terazosin HCl Tablet Develop a dissolution method 09/15/2023
Terazosin HCl Capsule Develop a dissolution method 09/15/2023
Terbinafine HCl Tablet II (Paddle) 50 Citrate Buffer, pH 3.0 adjusted with HCl 500 10, 20, 30 and 45 02/20/2004
Terconazole Suppository (Vaginal) I (with Palmieri type basket) 100 0.12 N HCl with 1% SLS 900 15, 30, 45, 60, 90, 120 and 150 10/08/2009
Teriflunomide Tablet II (Paddle)  50 0.05 M Phosphate Buffer, pH 6.8  1000 5, 10, 15, 20, 30 and 45 05/15/2014
Testosterone Film, Transdermal (Extended Release)  V (Paddle over disk). Paddle 25 mm above the film on the disk. 50 0.1 M sodium chloride containing 2.5% (v/v) of Tween 40 at 32 ± 0.5°C. Delivery surface faces upwards towards the media. 900 1, 3, 5, 7, 11, 16, 20 and 24 hours 06/30/2011
Testosterone Buccal Tablet (Extended Release) Develop a dissolution method 09/15/2023
Testosterone Pellet Implant Develop a dissolution method  11/25/2008
Testosterone Undecanoate Capsule II (Paddle) 75 Phosphate buffer pH 6.8 with 1.0% Triton X-100 900 10, 15, 20, 30 and 45 08/19/2021
Testosterone Undecanoate Capsule II (Paddle) 75 0.01 N HCl with 0.5% Triton X 100 900 5, 10, 15, 30, 45 and 60 02/05/2024
Tetrabenazine Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 30 and 45  09/01/2011
Tetracycline HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tetracycline HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Thalidomide Capsule II (Paddle) 100 1.5% (w/v) SLS (pH 3.0, adj w/ HCl) 900 10, 20, 30, 60 and 90 03/04/2006
Theophylline Capsule (Extended Release) Refer to USP 900 10/06/2008
Theophylline (100 mg and 200 mg) Tablet (Extended Release) II (Paddle) 50 SGF without Enzyme, pH 1.2 during 1st hour. Phosphate Buffer at pH 7.5 from end of hour 1 through the duration of testing 900 1, 4, 8, 12 hours 10/06/2008
Theophylline (300 mg and 450 mg) Tablet (Extended Release) II (Paddle) 50 SGF without Enzyme, pH 1.2 during 1st hour. Phosphate Buffer at pH 7.5 from end of hour 1 through the duration of testing 900 1, 4, 8, 12 hours 10/06/2008
Theophylline (600 mg and 400 mg) Tablet (Extended Release)  I (Basket) 100 SGF without enzyme, pH 1.2 during 1st hour. SIF without enzyme from end of hour 1 through the duration of the testing 900 1, 2, 4, 8, 12 and 24 hours 10/06/2008
Thioguanine Tablet Develop a dissolution method 01/03/2024
Tiagabine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Ticagrelor Tablet Develop a dissolution method 09/15/2023
Ticlopidine HCl Tablet Develop a dissolution method 09/15/2023
Timolol Maleate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tinidazole Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tiopronin Tablet  Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tiopronin Tablet (Delayed Release) I (Basket) 100 Acid Stage: 0.1 N HCl; Buffer Stage: 50 mM Potassium phosphate, pH 6.8 Acid Stage: 900; Buffer Stage: 900 Acid Stage:120; Buffer Stage:10, 20, 30, 45 and 60 07/07/2022
Tipiracil HCl/Trifluridine Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 11/02/2017
Tipranavir Capsule II (Paddle) 50 0.05 M phosphate buffer pH 6.8 900 15, 30, 45 and 60 12/03/2007
Tivozanib HCl Capsule II (Paddle with sinker) 50 Tier I: 0.1 mM HCI with 0.5% (w/v) sodium dodecyl sulfate (SDS) (900 mL); Tier II: 0.1 mM HCI with pepsin (as per USP) (750 mL) for the first 10 minutes, followed by addition of 0.1 mM HCI with SDS (3% w/v) (150 mL) for the remainder of the dissolution 900 5, 10, 15, 20 and 30 02/09/2023
Tizanidine HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tizanidine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tofacitinib Citrate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tofacitinib Citrate Tablet (Extended Release) II (Paddle) with option to use a sinker  50 Phosphate Buffer, pH 6.8 900 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours 07/28/2016
Tolcapone Tablet Refer to USP  05/09/2013
Tolterodine Tartrate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tolterodine Tartrate Capsule (Extended Release) I (Basket) 100 Phosphate buffer (pH 6.8) 900 1, 3, 7 hours 06/18/2007
Tolvaptan Tablet Develop a dissolution method 09/15/2023
Topiramate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Topiramate Capsule (Sprinkle) Develop a dissolution method 09/15/2023
Topiramate [25, 50, 100, 150 mg and 200 mg] Capsule (Extended Release) I (Basket) 100 50 mM Tris buffer, pH 7.2 900 0.5, 1, 2, 4, 6 and 8 hours 06/25/2015
Topiramate [25, 50, 100 and 200 mg] Capsule (Extended Release) II (Paddle) 50 0.05 M Phosphate Buffer, pH 7.5 750 1, 2, 3, 4, 6 and 8 hours 08/14/2014
Topotecan HCl Capsule II (Paddle) 50 Acetate Buffer with 0.15% SDS, pH 4.5 500 5, 10, 20, 30 and 45 04/27/2009
Toremifene Citrate Tablet II (Paddle) 50 0.02 N HCl 1000 10, 20, 30 and 45 02/20/2004
Torsemide Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/20/2004
Torsemide [20, 40 and 60 mg] Tablet II (Paddle) 75 0.1 N HCl 900 1, 2, 3, 4, 6, 8 and 10 hours 07/07/2022
Tramadol Capsule (Extended Release) Develop a dissolution method 09/15/2023
Tramadol HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tramadol HCl Tablet (Extended Release) I (Basket) 75 0.1 N HCl 900 2, 4, 8, 10 and 16 hours 01/03/2007
Trametinib Dimethyl Sulfoxide Tablet II (Paddle) 60 pH 4.5, 50 mM Sodium Acetate with 0.75% Sodium Lauryl Sulfate [SLS] 500 5, 10, 15, 20 and 30 12/24/2015
Trandolapril Tablet Develop a dissolution method 09/15/2023
Trandolapril/Verapamil HCl Tablet (Extended Release) II (Paddle) 50 Trandolapril: Develop a dissolution method; Verapamil: 0-1 hour Gastric Fluid w/o Pepsin pH=1.2, 1-8 hour Intestinal Fluid w/o Pancreatin Verapamil: 900 Verapamil: 1, 2, 3.5, 5 and 8 hours 09/15/2023
Tranexamic Acid Tablet  Develop a dissolution method 09/15/2023
Tranylcypromine Sulfate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Trazodone HCl Tablet (Extended Release)  Develop a dissolution method 09/15/2023
Trazodone HCl Tablet Refer to USP 05/18/2023
Treprostinil Diolamine Tablet (Extended Release)  I (Basket) 100 0.05 M Phosphate Buffer, pH 6.8 (deaerated) 500 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 06/02/2016
Tretinoin Capsule I (Basket) 100 0.5% solid Lauryldimethylamine-oxide (LDAO) in 0.05M Phosphate Buffer, pH 7.8 900 10, 15, 20, 30 and 45 08/05/2010
Triamcinolone Acetonide Injectable Suspension  Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 01/15/2010
Triamcinolone Acetonide Intra-Articular, For Suspension (Extended Release) II (Paddle) 75 0.3% SDS in 10 mM phosphate buffer, pH 7.2 + 0.02% sodium azide @35°C 1000 1, 2, 4, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours 02/08/2018
Triclabendazole Tablet II (Paddle) 75 0.1N HCl with 1% Tween 20 1000 5, 10, 15, 20 and 30 08/27/2020
Trientine HCl Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Trimethoprim Tablet Refer to USP  01/29/2010
Trimipramine Maleate Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Triptorelin Pamoate For Intramuscular Suspension (Extended Release) II (Paddle) 75 50 mL of methanol to 950 mL of water 950 1, 8, 24, 96, and 168 hours 11/16/2017
Triptorelin Pamoate Injectable Suspension II (Paddle) 200 Water-Methanol (95:5); Reconstitute vial in 2 mL Water for Injection, add to 500 mL medium at 37°C 500 1, 6, 12, 24, 48 and 72 hours 07/14/2008
Trospium Chloride Capsule (Extended Release) II (Paddle) with sinker 50 0.1 N HCl, pH 1.1 for 2 hrs and then add 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 7.5 using 2 N HCl and/or 2N NaOH 0-2 hrs: 750 ml, After 2 hrs: 950 ml. 2, 3, 4, 6, 8, 12 and 16 hours 07/15/2010
Trospium Chloride Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Tucatinib Tablet II (Paddle) 75 0.1 M Citrate Buffer, pH 3.4, containing 0.05% Brij 35 (polyoxyethylene lauryl ether) 900 10, 15, 20, 30 and 45 05/12/2022
Ulipristal Acetate Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30  01/31/2013
Upadacitinib Tablet (Extended Release) I (Basket) 100 50 mM Phosphate buffer, pH 6.8 [for 15 mg and 30 mg strengths]; 25 mM Phosphate buffer with 2.75% NaCl, pH 6.8 for [45 mg strength] 900 1, 2, 4, 6, 8, 12 and 16 hours 02/09/2023
Uridine Triacetate Granule II (Paddle) 60 50 mM Phosphate Buffer, pH 6.8 900 10, 15, 20, 30, 45 and 60 07/07/2022
Ursodiol Capsules Refer to USP 07/21/2009
Ursodiol Tablet Refer to USP 04/15/2008
Valacyclovir Hydrochloride Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Valbenazine Capsule II (Paddle) with sinker 50 Tier 1: 0.1N HCl; Tier 2: 0.1N HCl containing pepsin (750,000 units per 1000 mL) 900 5, 10, 15, 20 and 30 11/02/2017
Valganciclovir HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Valproic Acid Capsule Refer to USP 12/15/2009
Valsartan Capsule II (Paddle) 50 0.067 M Phosphate Buffer, pH 6.8 1000 10, 20, 30 and 45 12/13/2004
Valsartan Tablet  Refer to USP  07/28/2016
Vancomycin hydrochloride Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Vandetanib Tablet II (Paddle) 50 pH 1.2 Buffer [0.05 M KCl in water, adjust the pH with HCl or NaOH] 1000 5, 10, 15, 20 and 30 06/25/2015
Vardenafil HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Vardenafil HCl Tablet (Orally Disintegrating)  II (Paddle)  50 0.1 N HCl  900 5, 10, 15 and 30  05/15/2014
Varenicline Tartrate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Vemurafenib Tablet II (Paddle) 75 1% hexadecyltrimethylammonium bromide (HTAB) in 0.05 M Phosphate Buffer, pH 6.8 900 10, 15, 20, 30 and 45 05/28/2015
Venetoclax Tablet  III (Reciprocating Cylinder) [Bottom Screen: 200 mesh stainless steel] 20 dpm Phosphate Buffer, pH 6.8 with 0.4% sodium dodecyl sulfate (SDS) [3 small drops of antifoaming agent may be used] 250 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 3.5 and 4 hours 07/28/2016
Venlafaxine Besylate Tablet (Extended Release) II (Paddle with sinker) 50 0.1 M NaCl in water (Degassed) 900 1, 2, 4, 6, 8, 12, 14 and 16 hours 02/09/2023
Venlafaxine HCl Capsule (Extended Release) Develop a dissolution method 09/15/2023
Venlafaxine HCl Tablet (Extended Release)  Develop a dissolution method 09/15/2023
Venlafaxine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Verapamil HCl Capsule (Extended Release) Refer to USP 08/27/2015
Verapamil HCl Tablet (Extended Release)  Refer to USP 06/24/2010
Verapamil HCl Tablet Refer to USP 11/04/2008
Vericiguat Tablet II (Paddle) 75 0.01 N HCl, pH 2.0 900 5, 10, 15, 20 and 30  07/07/2022
Verteporfin Injectable Develop a method to characterize in vitro release. 08/14/2014
Vibegron Tablet Refer to FDA's Dissolution Guidance, 2018 02/09/2023
Vigabatrin Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Vilazodone HCl Tablet II (Paddle) 60 0.1% v/v Glacial acetic acid solution (pH 3.1) 1000 10, 15, 20, 30 and 45 08/14/2014
Viloxazine HCl Capsule (Extended Release) II (Paddle) with sinker 50 pH 6.8 Phosphate Buffer 900 1, 2, 4, 6, 8, 10, 12 and 16 hours 07/07/2022
Vismodegib Capsule II (Paddle) 75 0.01 N HCl with 1.0% sodium lauryl sulfate (SLS) 900 10, 15, 20, 30 and 45 05/28/2015
Voclosporin Capsule II (Paddle) 75 0.75% of Polyoxyl 40 hydrogenated castor oil in sodium acetate buffer (22mM), pH 4.5 900 10, 20, 30, 45 and 60 02/09/2023
Vorapaxar Sulfate Tablet II (Paddle) 50 41 mM Na2HPO4, 1.5% Citric Acid, pH 3.0 ± 0.5 900 5, 10, 20, 30, 45 and 60 12/24/2015
Voriconazole Suspension II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 01/03/2007
Voriconazole Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 11/25/2008
Vorinostat Capsule Develop a dissolution method 09/15/2023
Vortioxetine HBr Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 45 05/28/2015
Voxelotor Tablet II (Paddle) 75 50 mM phosphate buffer (pH 6.8) with 2% sodium lauryl sulfate (SLS) 900 5, 10, 20, 30 and 45 07/28/2022
Voxelotor Tablet, for Suspension II (Paddle) 75 50 mM phosphate buffer (pH 6.8) with 2% sodium lauryl sulfate (SLS) 900 5, 10, 15, 20 and 30 07/28/2022
Warfarin Sodium Tablet Develop a dissolution method 01/03/2024
Zafirlukast Tablet II (Paddle) 50 1% w/v Aqueous Sodium Dodecyl Sulfate 1000 10. 30, 30 and 45 10/09/2007
Zalcitabine Tablet Develop a dissolution method 01/03/2024
Zaleplon Capsule Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Zidovudine Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Zileuton Tablet (Extended Release)   Develop a dissolution method 09/15/2023
Zileuton Tablet Develop a dissolution method 09/15/2023
Zinc Acetate Capsule II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 02/19/2004
Ziprasidone HCl Capsule II (Paddle) 75 Tier I: 0.05 M Na phosphate buffer, pH 7.5 + 2% SDS (w/w) Tier II: 0.05 M Na phosphate buffer, pH 7.5 (700ml) + 1% pancreatin. After 15 min. incubation, add 200 mL of phosphate buffer containg 9% SDS 900 10, 20, 30, 45 and 60 03/04/2006
Zolmitriptan Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Zolmitriptan Tablet (Orally Disintegrating) II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 20 and 30 06/18/2007
Zolpidem Tartrate Tablet Refer to FDA's Dissolution Guidance, 2018 07/02/2020
Zolpidem Tartrate Tablet (Extended Release) Refer to USP  01/05/2012
Zolpidem Tartrate (1.75 and 3.5 mg) Tablet (Sublingual) II (Paddle) 50 Simulated intestinal fluid (without enzyme), pH 6.8, (deaerated) 500 1, 3, 5, 7, 10 and 15 08/14/2014
Zolpidem Tartrate (5 and 10 mg) Tablet (Sublingual) II (Paddle) 75 Phosphate Buffer, pH 6.8 900 1, 3, 5, 7, 10 and 15 08/14/2014
Zonisamide Capsule  Develop a dissolution method 09/15/2023
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